CRUX® VENA CAVA FILTER (VCF) ENGLISH -...
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2 ENGLISH CRUX® VENA CAVA FILTER (VCF) Outer Shaft Handle Outer Shaft Tracking Tip Check Valve Outer Shaft Flush Port Inner Shaft Guidewire Port Hemostasis Valve Inner Shaft Radiopaque Marker Band 501-0100.39/003 Figure 2 CAUTION: 1. U.S. Federal Law restricts this device to sale by or on the order of a physician 2. Prior to use, read this entire Instructions For Use. INTENDED USE: The Crux® VCF is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava (IVC) in the following situations: • Pulmonary thromboembolism when anticoagulants are contraindicated • Failure of anticoagulant therapy in thromboembolic diseases • Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced • Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated The Crux® VCF may be removed according to the instructions contained in the section “Optional Retrieval of the Crux VCF” in patients who no longer require a vena cava filter. Retrieval of the filter can be performed by femoral or jugular approach. The product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard endovascular techniques for placement of vascular access sheaths, angiographic catheters and guide wires should be employed. DESCRIPTION: TheVolcano Corporation CruxVena Cava Filter (CruxVCF) is an endovascular medical device used in the prevention of recurrent pulmonary embolism (PE). The CruxVCF Filter consists of a self-expanding nitinol filter delivered via a one-time-use disposable delivery catheter. The filter is composed of two opposing, self-expanding nitinol spiral wireforms connected at the ends. One end of each wireform is formed into a sinusoidal-shaped retrieval tail to aid in retrieval of the filter using a snare. Each retrieval tail has an atraumatic tip and a radiopaque tantalum marker band to facilitate visualization during retrieval. Five tissue anchors are attached to the spiral wireforms. The clot trapping portion of the filter is formed from a web of ePTFE filaments attached to the wireforms using PTFE/FEP tubing (see Figure 1). One filter size is available to treat inferior vena cava (IVC) inner diameters (ID) from 17mm to 28mm. The CruxVCF comes in two pre-loaded configurations: one for delivery of the filter using a femoral approach and one for delivery of the filter via a jugular approach. The delivery catheter for the CruxVCF is a disposable, 9Fr introducer-sheath-compatible, single-use delivery catheter designed for controlled deployment of the filter (see Figure 2). The delivery catheter is an over-the-wire catheter, 0.035”guide wire-compatible, and consists of a polycarbonate inner shaft and a nylon outer shaft. The inner shaft consists of the guide wire lumen and a flexible, radiopaque tracking tip. The outer shaft has a radiopaque distal marker band, aTouhy-Borst hemostasis valve and a one-way check valve for flushing.The filter can be retrieved with commercially available snares and sheaths via either the jugular or femoral approach. CONTRAINDICATIONS: Do not use the CruxVCF in patients who do not meet the intended use and indications including: uncontrolled sepsis, risk of septic embolism, IVC diameter below 17 mm or above 28 mm, contraindications to endovascular procedures done under fluoroscopic guidance, sensitivity to any materials used in the CruxVCF, retrieval of the filter with significant thrombus in or near the filter, pregnant patients where fluoroscopy may endanger the fetus. ADVERSE EFFECTS: A full explanation of the risks and benefits should be discussed with each prospective patient prior to implantation. Adverse effects range from mild to serious. Serious adverse effects, sometimes leading to surgical intervention or death, have been associated with the use of IVC filters. In addition, complications due to individual patient reaction to an implanted device, or to physical or chemical changes in the components, may necessitate reoperation and replacement of the filter. Possible adverse effects associated with IVC filters include, but are not limited to, the following: arrhythmia, arteriovenous fistula, back or abdominal pain, contrast media extravasation at time of vena cavogram, death, deep vein thrombosis, delivery system detachment or embolization, emboli (air, thrombotic or tissue), filter expansion failure, filter or device entanglement, fever, filter fracture, filter thrombosis or occlusion, filter malpositioned, mis-oriented or compressed, filter migration, filter embolization, guide wire entrapment , hematoma or nerve injury at the puncture site or subsequent retrieval site, hemorrhage with or without transfusion, hemothorax, inability to retrieve filter, infection, intimal tear, occlusion of small vessels, organ injury, pain or discomfort, perforation or other acute or chronic damage of the IVC wall, phlegmasia cerulean dolens, phneumothorax, post phlebitis syndrome, pulmonary embolism (recurrent or new), renal injury or failure, restriction of blood flow, stenosis at implant site, stroke, thrombosis, venous ulceration, vessel dissection, perforation, ulceration or rupture, vessel spasm. 501-0000.37_008 IFU, MULTI-LANG, CRUX VENA CAVA FILTER SYSTEM.indd 2 10/22/2014 12:45:00 PM
Transcript of CRUX® VENA CAVA FILTER (VCF) ENGLISH -...
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ENGLISHCRUX® VENA CAVA FILTER (VCF)
Outer Shaft HandleOuter Shaft
Tracking Tip
Check Valve
Outer Shaft Flush Port
Inner ShaftGuidewire Port
Hemostasis Valve
Inner Shaft
Radiopaque Marker Band501-0100.39/003
Figure 2
Wireform
ePTFE Filter Web
Caudal Marker Band
Cranial Marker Band
Caudal Retrieval Tail501-0100.38/002Figure 1
Side Tissue Anchor Extended Tissue Anchor
Cranial Retrieval Tail
CAUTION:1. U.S. Federal Law restricts this device to sale by or on the order of a physician 2. Prior to use, read this entire Instructions For Use.INTENDED USE:The Crux® VCF is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava (IVC) in the following situations: • Pulmonarythromboembolismwhenanticoagulantsarecontraindicated • Failureofanticoagulanttherapyinthromboembolicdiseases • Emergencytreatmentfollowingmassivepulmonaryembolismwhereanticipatedbenefitsofconventionaltherapyarereduced • Chronic,recurrentpulmonaryembolismwhereanticoagulanttherapyhasfailedoriscontraindicatedThe Crux® VCF may be removed according to the instructions contained in the section “Optional Retrieval of the Crux VCF” in patients who no longer require a vena cava filter.Retrievalofthefiltercanbeperformedbyfemoralorjugularapproach.Theproductisintendedforusebyphysicianstrainedandexperiencedindiagnosticandinterventionaltechniques.Standardendovasculartechniquesforplacementofvascularaccesssheaths,angiographiccathetersandguidewiresshouldbeemployed.DESCRIPTION:TheVolcanoCorporationCruxVenaCavaFilter(CruxVCF)isanendovascularmedicaldeviceusedinthepreventionofrecurrentpulmonaryembolism(PE).TheCruxVCFFilterconsistsofaself-expandingnitinolfilterdeliveredviaaone-time-usedisposabledeliverycatheter.Thefilteriscomposedoftwoopposing,self-expandingnitinolspiralwireformsconnectedattheends.Oneendofeachwireformisformedintoasinusoidal-shapedretrievaltailtoaid inretrievalofthefilterusingasnare.Eachretrievaltailhasanatraumatictipandaradiopaquetantalummarkerbandtofacilitatevisualizationduringretrieval.Fivetissueanchorsareattachedtothespiralwireforms.TheclottrappingportionofthefilterisformedfromawebofePTFEfilamentsattachedtothewireformsusingPTFE/FEPtubing(see Figure 1).Onefiltersizeisavailabletotreatinferiorvenacava(IVC)innerdiameters(ID)from17mmto28mm.TheCruxVCFcomesintwopre-loadedconfigurations:onefordeliveryofthefilterusingafemoralapproachandonefordeliveryofthefilterviaajugularapproach.ThedeliverycatheterfortheCruxVCFisadisposable,9Frintroducer-sheath-compatible,single-usedeliverycatheterdesignedforcontrolleddeploymentofthefilter(see Figure 2).Thedeliverycatheterisanover-the-wirecatheter,0.035”guidewire-compatible,andconsistsofapolycarbonateinnershaftandanylonoutershaft.Theinnershaftconsistsoftheguidewirelumenandaflexible,radiopaquetrackingtip.Theoutershafthasaradiopaquedistalmarkerband,aTouhy-Borsthemostasisvalveandaone-waycheckvalveforflushing.Thefiltercanberetrievedwithcommerciallyavailablesnaresandsheathsviaeitherthejugularorfemoralapproach.CONTRAINDICATIONS:DonotusetheCruxVCFinpatientswhodonotmeettheintendeduseandindicationsincluding:uncontrolledsepsis,riskofsepticembolism,IVCdiameterbelow17mmorabove28mm,contraindicationstoendovascularproceduresdoneunderfluoroscopicguidance,sensitivitytoanymaterialsusedintheCruxVCF,retrievalofthefilterwithsignificantthrombusinornearthefilter,pregnantpatientswherefluoroscopymayendangerthefetus.ADVERSE EFFECTS:A full explanation of the risks and benefi ts should be discussed with each prospective patient prior to implantation. Adverse eff ects range from mild to serious. Serious adverse eff ects, sometimes leading to surgical intervention or death, have been associated with the use of IVC fi lters. In addition, complications due to individual patient reaction to an implanted device, or to physical or chemical changes in the components, may necessitate reoperation and replacement of the fi lter.Possible adverse eff ects associated with IVC fi lters include, but are not limited to, the following: arrhythmia, arteriovenous fi stula, back or abdominal pain, contrast media extravasation at time of vena cavogram, death, deep vein thrombosis, delivery system detachment or embolization, emboli (air, thrombotic or tissue), fi lter expansion failure, fi lter or device entanglement, fever, fi lter fracture, fi lter thrombosis or occlusion, fi lter malpositioned, mis-oriented or compressed, fi lter migration, fi lter embolization, guide wire entrapment , hematoma or nerve injury at the puncture site or subsequent retrieval site, hemorrhage with or without transfusion, hemothorax, inability to retrieve fi lter, infection, intimal tear, occlusion of small vessels, organ injury, pain or discomfort, perforation or other acute or chronic damage of the IVC wall, phlegmasia cerulean dolens, phneumothorax, post phlebitis syndrome, pulmonary embolism (recurrent or new), renal injury or failure, restriction of blood fl ow, stenosis at implant site, stroke, thrombosis, venous ulceration, vessel dissection, perforation, ulceration or rupture, vessel spasm.
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WARNINGS:• TheCruxVCFisforsingleuseonly.• Donotreuse,re-sterilizeorreprocess.Impairmentofstructuralintegrityorfunctionmayresultfromreuse,re-sterilizationorreprocessingofthedevice, possiblyleadingtoadversepatientreactions.• Donotuseifpackagingisdamaged.Uponremovalfromtheouterbox,inspectthepackagingandproducttoensurenodamagehasoccurred.• Alldevicemanipulationsshouldbeunderfluoroscopicguidance.Neveradvanceormanipulatethedevicesoranyaccessoriesduringdeploymentorretrieval withoutfluoroscopicguidance.Ultrasoundmaybeusedasacomplementaryimagingmodalitywhenappropriate.DonotdeploythefilterunlesstheIVChasbeen properlymeasured.• Excessiveforceshouldnotbeusedtodeployorretrievethefilter.• Donotattempttorepositionthefilterafterithasbeendeployed.• Donotabortdeploymentorre-sheathoncefilterretrievaltailisexposedfromtheoutersheath• DonotdeploythefilterpriortoproperpositioningintheIVC,asthefiltercannotbesafelyreloadedorredeployed.• Filterfracturesareaknowncomplicationofvenacavafilters.Therehavebeenreportsofseriouspulmonaryandcardiaccomplicationswithvenacavafilters requiringtheretrievalofthefragmentutilizingendovascularandorsurgicaltechniques.• Movement,migrationand/ortiltareknowncomplicationsofvenacavafilters.Migrationoffilterstotheheartorlungshasbeenreported.Therehavealsobeen reportsofcaudalfiltermigration.MigrationmaybecausedbyplacementinIVCswithdiametersexceedingthedimensionsspecifiedintheIFU.Migrationmayalso] becausedbyimproperdeployment,deploymentintoclotsand/ordislodgementduetolargeclotburdens.• NeverusethejugulardeliverysystemforthefemoralapproachasthiswillresultinimproperfilterorientationwithintheIVC.• NeverusethefemoraldeliverycatheterforthejugularapproachasthiswillresultinimproperfilterorientationwithintheIVC.• TheCruxVCFconsistsofnickel-titaniumalloywhichisgenerallyconsideredsafe.Patientswhoareallergictonickelmayhaveanallergicreactiontothisdevice, especiallythosewithahistoryofmetalallergies.• Donotattempttodeliverthefilteriflargethrombusispresentattargeteddeliverysite.• DonotremovetheCruxVCFifthrombusistrappedwithinthefilter.• Afterfilterimplantation,anycatheterizationprocedurerequiringpassageofadevicemaybeimpeded.• Afteruse,theCruxVCFandaccessoriesshouldbetreatedasabiohazard..Handleanddisposeofinaccordancewithacceptedmedicalpracticeandapplicable localstateandfederallawsandregulations.ThedecisiontouseanIVCfiltermustultimatelybemadebythephysicianonanindividualpatientbasisaftercarefullyevaluatingtheintendeduseandindicationsandtheshortandlongtermrisksandbenefitstothepatientascomparedtoalternativemethodsoftreatment.PRECAUTIONS:TheCruxVCFisadelicatescientificinstrumentandshouldbetreatedassuch.Alwaysobservethefollowingprecautions:For Vena Cava Filter Placement• Whenusingthefemoralpercutaneousapproach,itmaybepreferabletousetherightfemoralveinduetothetortuosityoftheleftfemoralvein.• Whenusingthejugularpercutaneousapproach,itmaybepreferabletousetherightinternaljugularvein.• UsepowercontrastinjectionsforIVCmeasurements.TheIVCdiametermustbe17mmto28mm. • TheCruxVCFcomespreloadedonadeliverycatheterspecificforeitherafemoralorajugularapproach.Donotdisassemble.• Ifanycomponentsaredisassembled,donotreassemblefordeployment.• Thefiltermaybepositionedpriortodrawingbacktheoutershaftorwithonlythefirstretrievaltailreleasedfromtheoutershaft.Donotattempttoreposition thefilteronceyouhavepassedthispoint.• Ifthefilterisdeployedinanincorrectpositionororientation,considerimmediateretrievalusingtheOptionalFilterRetrievalprocedures.Donotrepositiona deployedfilter.• Thefiltermayforeshortenasitisdeployed(caudallyforafemoralapproachandcraniallyforajugularapproach).Considerthiswhenpositioningthefilter during the deployment procedure (see Table 2). • Followingimplantationofthefilter,subsequentvenacavacatheterizationproceduresmaybeimpededbythepresenceofthefilter.• Anatomicalvariancesmaycomplicatefilterinsertionanddeployment.For Optional Filter Retrieval • Aninferiorvenacavagramevaluationforthrombusshouldbeperformedpriortoattemptedretrieval.• Donotattemptretrievalifthrombusispresentinthefilterand/orcaudaltothefilter.• Donotredeployaretrievedfilter.Itshouldbehandledanddisposedofinaccordancewithacceptedmedicalpracticeandapplicablelocalstateandfederal lawsandregulations.• Anatomicalvariancesmaycomplicatetheremovalprocedure.NOTE: The safety and effectiveness of this device has been established for the cohort studied under the clinical investigation and has not been established for pediatric patients,pregnantfemalesorforsuprarenalplacement.NOTE: StandardandguidelinesdevelopedbytheSocietyofInterventionalRadiologyrecommendthatpatientswithfilters,permanentorretrievable,aretrackedandshouldreceivefollowupvisitssubsequenttotheplacementofthefilter.FDArecommendsthatimplantingphysiciansresponsiblefortheongoingcareofpatientswithretrievableIVCfiltersshouldconsiderremovingthefilterassoonasitisnolongerneeded.FDAencouragesallphysiciansinvolvedinthetreatmentandcareofIVCfilterrecipientstoconsidertherisksandbenefitsoffilterremovalforeachpatient.SOURCE: Reporting Standard for Inferior Vena Cava Filter Placement and Patient Follow-up Supplement for Temporary and Retrievable/Optional Filters. Millward,S., et al.: J. Vasc Interv Radiol 2005; 16:441-443; Recommended Reporting Standard for Vena Cava Filter Placement and Patient Follow-up. The Participants in the Vena Cava Filter Consensus Conference: J Vasc Inter Radiol 2003; 14:S427-S432; Guidelines for the Use of Retrievable and Convertible Vena Cava Filters: Report from the Society of Interventional Radiology multidisciplinary Consensus Conference. Kaufman, J., et al.: J Vasc Inter Radiol 2006; 17:449-459HOW SUPPLIED: • TheCruxVCFissterilizedusingethyleneoxidegasinpeel-openpackages,andisnon-pyrogenic. • TheCruxVCFissterileifpackageisunopenedandundamaged. • TheCruxVCFissuppliedintwoversions:Femoralveindelivery(REF7024)andJugularveindelivery(REF7025).
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MRI COMPATIBILITY:Non-clinicaltestinghasdemonstratedthattheCruxVCFisMRConditional.PatientswithaCruxvenacavafiltercanbescannedsafely,immediatelyafterimplantation,under the following conditions: • Staticmagneticfieldof1.5Tesla(1.5T)or3.0Tesla(3.0T). • Maximumspatialgradientfieldlessthanorequalto25T/m(2,500G/cm). • Maximumspecificabsorptionrate(SAR)of2W/kginnormaloperatingmodefor15minutesofscanningat1.5Tand3.0T.3.0T RF HeatingInnon-clinicaltestingwithbodycoilexcitation,theCruxvenacavafilterproducedamaximaldifferentialtemperatureriseof4.5°Catamaximumspecificabsorptionrate(SAR)of3.4W/kgfor15minutesofscanningina3.0-TeslaMRsystem(SiemensTrio,SYNGOMRA304VA30Asoftware,Munich,Germany).ScalingoftheSARandobservedheatingindicatesthataSARof2W/kgwouldbeexpectedtoyieldalocalizedtemperatureriseof2.6°C.1.5T RF HeatingInnon-clinicaltestingwithbodycoilexcitation,theCruxvenacavafilterproducedamaximaltemperatureriseof3.5°Catamaximumspecificabsorptionrate(SAR)of1.6W/kgfor15minutesofscanningina1.5-TeslaMRsystem(SiemensEspree,SYNGOMRB15software,Munich,Germany).ScalingoftheSARandobservedheatingindicatesthataSARof2W/kgwouldbeexpectedtoyieldalocalizedtemperatureriseof4.4°C.CAUTION: TheRFheatingbehaviordoesnotscalewithstaticfieldstrength.Deviceswhichdonotexhibitdetectableheatingatonefieldstrengthmayexhibithighvaluesoflocalizedheatingatanotherfieldstrength.MR ArtifactsIngradientandspinechosequences,theimageartifactextendsapproximately8mmfromtheCruxvenacavafilter. ItmaybenecessarytooptimizeMRimagingparametersforthepresenceofthismetallicimplant.OtherMagneticallyinduceddisplacementforceandtorquetestingindicatedthattheimplantposednoknownrisksfrommagneticallyinduceddisplacementorforcewhensubjectedtotheMRenvironmentdescribedintheconditionsabove.PhysiciansshouldencouragepatientstoregistertheabovesafescanningconditionswithMedicAlertFoundation(www.medicalert.org)orequivalentorganization.CLINICAL STUDIES:Amultinationalinvestigationalstudywasconductedtoassessthesafety,performanceandeffectivenessoftheCruxVCFasbothretrievableandpermanentdevice.Thestudywasaprospectivesingle-armcomparingtheresultstoapre-establishedperformancegoal.TheprimaryendpointwasClinicalSuccessdefinedasacompositeof technical success,and freedomfrompulmonaryembolism,migrationoradevice relatedadverseevent requiring intervention. ThestudyhypothesisofClinicalSuccesswouldbemetifthelowerlimitoftheone-sided95%confidenceintervalwasnotbelow80%.Secondaryendpointsincludedretrievalsuccess,migration,IVCFthrombusanddeviceintegrity.Onehundred and twenty-five (125) subjects at high risk for pulmonary embolism (PE)were enrolled. Of the125, 73 (58%)male and52 (42%) femalewereincludedwithameanageof59.6±17.2. Theprimary three reasons forfilter implantweresurgical risk (36%),presenceofDVT(15%)andcontraindication to
anticoagulation (14%). The four primary thromboembolic risk factors wereoverall, thromboembolic risk factors DVT at baseline (58.4%), history ofDVT (49.6%), contraindication to anticoagulation (37.6%) and history of PE(36.8%).Allsubjectshadoneormorethromboembolicriskfactors.Filterdeploymenttechnicalsuccessoccurredin123/125(98%).Intwocases,thephysicianschoosetoretrievethefilter immediatelybecauseof inaccuratedeployment and replace with commercially available filters. There were noadverseclinicalsequelaeinthosetwosubjects.Fiftythree(53)of54patientshadtheirfiltersuccessfullyretrieved.Theaveragetime to retrievalwas85±58days (see Figure 3). One (1)filter couldbenotretrievedat167daysduetoexcessiveforce.Afemoralretrievalapproach
wasusedin37procedures(70%).RetrievalSuccesswasachievedin98%withonly1radiographicanomalyobservedatretrievalwithnoclinicalsequelae.Forty-nine (49) subjects completed the study with a permanentfilterinsituat180days.Twenty-two,(16%)didnotcompletethestudy:14(11%)patientsdiedduetopre-existingorotherreasonsunrelatedtothestudy,6(5%)subjectswithdrewand2(<2%)werelosttofollowup. Nopatientdeathswereattributedtothefilter,deploymentorretrievalproceduresbasedonindependentMedicalMonitoradjudication.During the course of the study, no embolization, migration orfractureswereobserved.Threesubjectshadpulmonaryembolisms(2.4%),confirmedbyCTorperfusionlungscan,and17subjectshadnewDVT(14%).Therewere8subjectswiththrombusobservedinornearthefilter(6%),primarilyatretrievalevaluations,nosubjectsweresymptomatic.TheprimaryendpointofClinicalSuccesswas96.0%(91.8%lowerone-sided 95% CL exceeding the 80% Lower Limit). Retrieval
successwas53/54(98%)averagetimetoretrievalwas85±58dayswith1radiographicanomalyobservedwithnoclinicalsequelae.Theclinicaltrialdemonstratedthesafedeployment,implantandretrievalofthefilter.Technicalandretrievalsuccessarehigh,withalowrateofdevicerelatedcomplications.Theobservedratesoffiltermigrationandpulmonaryembolizationwereconsistentwithpublishedliterature.Foradditionalinformationonsubjectdisposition(seeTable1).INSTRUCTIONS FOR USE:For Deployment• Standardmicro-puncturesettoobtainpercutaneousaccess• 9Fshortintroducersheathifdesired• 0.035”(outerdiameter)guidewirewithaminimumlengthof180cm• Sizingangiographiccatheter
Eligiblefor Visit
Baseline
30 Days
90 Days
180 Days
125
105
70
49
6
6
2
N/A
0
1
1
N/A
14
23
16
N/A
0
3
22
N/A
20
351
21
N/A
DeathLost to
Follow-up
Table 1 - Subject Accountability for the Crux Vena Cava Filter Study
1 Per protocol, two subjects exited at 30 days due to no implant (technical failures)2 There was an additional withdrawal post retrieval for one subject which does not show up on this table.NA=Not applicable.
Retrieved
Events Occurring Prior to Next Visit
Subject Accountability for Crux Vena Cava Filter Study
WithdrawalNot DueFor Next
Visit
For Retrieval• Standardmicro-puncturesettoobtainobtainpercutaneousaccess• 0.035”(outerdiameter)guidewirewithaminimumlengthof180cm• Angiographiccatheter• 6Fx90cmtipsheath• 10Fx80cmtipsheath
includedwithameanageof59.6±17.2. Theprimary three reasons forfilter implantweresurgical risk (36%),presenceofDVT(15%)andcontraindication to
15
10
5
0
Figure 3 - Filter Time from Implantation to Retrieval
Time from Implantation to Retrieval
No. of Days to Successful Retrieval
No. o
f Filt
er R
etrie
vals
30
31 - 60
61 - 90
91 - 120
121 - 150
151 - 180
181 - 190
<_
IVC Diameter (mm)
171819202122232425262728
83828078777573737270696765
56555453525150504948474644
Table 2 - Estimated deployed length is derivedfrom a benchtop IVC model.
Overall FilterLength (mm)
Anchor to caudal tail length (mm)
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PreparingtheCruxVCF(FemoralREF7024orJugularREF7025)forthefilterimplantationprocedure.ImplantingoftheCruxVCFcanbedonebyeithertheFemoral(REF7024)orJugular(REF7025)approach.Ensureyouselectthecorrectproductfortheintendedapproach.Inspection Prior to Use Carefullyinspectthepackagepriortouseforanybreachofthesterilebarrierordamagetothecontents.Ifthesterilebarrierintegrityiscompromisedorthecontentsdamaged,contactyourVolcanoCorporationrepresentative.Preparation For Use1. Openouterpouchattheguidewireportend,andtransfertheinnerpouchanddevicetosterilefieldusingaseptictechnique.2. Opentheinnerpouchattheguidewireportend,andremovedevicefrompouch.3. Removethestyletfromthedistaltipofthedeliverycatheteranddiscard.4. CarefullyremovetheCruxVCFfromtheinsertcardandinspectthedevicefordamage.WARNING:Donotusethedeviceifanydamageexistsonthedevice.5. Tightenthehemostasisvalveontheoutershafthandle.6. Fastencheckvalvetooutershaftflushport.7. Usingnormalsterileheparinizedsaline,flushtheoutershaftlumenthroughthehandleflushportwhileoccludingtheinnershaftguidewireport.Verifythat theflushisobservedexitingthedistalendoftheoutershaftofthedeliverycatheter.8. Usingnormalsterileheparinizedsaline,flushtheguidewirelumenthroughtheguidewireport.Verifythattheflushisobservedexitingthedistalendofthe trackingtipofthedeliverycatheter.NOTE: All catheter or Crux VCF manipulations should be done while using fl uoroscopy imaging guidance.9. Accesseitherthefemoralorjugularveinusingstandardpercutaneoustechnique.10. Placea0.035”guidewireintotheveinandadvancetotargetsite.11. Advanceameasuring pigtail catheterovertheguidewiretotargetsite.Removeguidewirefrompigtailcatheter.12.Withpowercontrastinjection,performavenacavagramofthetargetsite.Assessvenacavadiameter.13.Removethepigtailcatheter,leavingguidewireinplace.
14.ProceedwithdeploymentiftheIVCtargetsitemeasures17mm to 28mmatitswidestdiameter.Asaguideline,
estimatesofdeployedfilterlengthareprovidedinTable2.15.Verifythatthehemostasisvalveontheoutershafthandleistight.LoadandadvancetheCruxVCFdeliverycatheterindicatedfortheintendedapproach(FemoralREF7024orJugularREF7025)overtheguidewireunderfluoroscopic guidancetothetargetsite.16.Usingfluoroscopicguidance,positiontheradiopaquemarkerbandjustabovetherenalveinsifusingthefemoralapproach;or,ifusingthejugularapproach,positiontheloadedcranialretrievaltailatthelevelofthelowestrenalvein.17.VerifyCruxVCFpositioningintheinferiorvenacavaandmakeadjustmentsasnecessary.
18.Loosenthehemostasisvalve.19.Maintainpositionoftheinnershaftsteady,andslowlypullbackontheoutershafthandletoinitiatedeployment.20.Uponexposureoftheretrievaltailduringdeployment: • Itispossibletostopandre-positionthefilter. • Donotattempttore-sheaththefilter.21. VerifyCruxVCFpositioningintheinferiorvenacavaandmakeadjustmentsasnecessary.CAUTION: Thefiltermayforeshortenasitisdeployed: • Femoral Approach: thecranialfiltertailmaylandup to 1.5cm caudal to the initial deployment location (see Figure 4). • Jugular Approach: the cranial tail may land up to 0.5cm caudal to the initial deployment location (see Figure 5).Consider this when positioning the fi lter during the deployment procedure. 22.Continuepullingbacktheoutershafthandleuntilthehemostasisvalvecontactsthe distaledgeofguidewireport.Ensurethathemostasisvalveispulledcompletelyback toallowfulldeploymentofthefilter.23.Tightenthehemostasisvalve.CAUTION: Donotattempttore-positionthefilter.Donotpushtheoutersheathbackoverthefilter.CAUTION:Avoidrotatingtheoutershafthandleduringshaftpullbackasthiscanresultinaninaccuratedeployment.NOTE: TheCruxVCFwillfullydeployandreleasefromthedeliverycatheteroncethehemostasisvalvecontactsthedistalendoftheguidewireport.Removal of the Delivery System Post Deployment1.Ensurethehemostasisvalvehasbeentightened.2. Usingfluoroscopy,ensurethetrackingtipisnotseatedagainsttheoutershafttopreventpossiblefilterdisplacement.3. Removethedeliverycatheterfromthepatientsuchthatthetipiscarefullypulledthroughthedeployedfilter.CAUTION:Ensurethatthedeliverycatheterdoesnotinteractwiththedeployedfilterduringwithdrawal,topreventshiftingofthefilter.4. Afterdeploymentoffilter,standardofcareshouldbefollowedforremovalofdevicesandestablishinghemostasistopreventbleedingatthevascular accesssite.Optional Retrieval of the Crux VCFNOTE:RetrievaloftheCruxVCFcanbeaccomplishedviaeitherthefemoralveinorthejugularvein.1. Accesseitherthefemoralorjugularveinusingstandardpercutaneoustechnique.2. Placea0.035”guidewireintotheveinandadvancetotargetsite3. Advanceanangiographiccatheterovertheguidewiretothetargetsite.Removeguidewirefrompigtailcatheter.4. PerformavenacavagramoftheIVCandfilterforthrombus.5. Reinsertguidewireintotheangiographiccatheter.Removetheangiographiccatheter,leavingtheguidewireinplace.
Figure 5Initial Jugluar Deployment Location
Figure 4Initial Femoral Deployment Location
Figure 4Initial Femoral Initial Femoral Deployment LocationDeployment LocationDeployment LocationDeployment Location
For Retrieval• Standardmicro-puncturesettoobtainobtainpercutaneousaccess• 0.035”(outerdiameter)guidewirewithaminimumlengthof180cm• Angiographiccatheter• 6Fx90cmtipsheath• 10Fx80cmtipsheath
IVC Diameter (mm)
171819202122232425262728
83828078777573737270696765
56555453525150504948474644
Table 2 - Estimated deployed length is derivedfrom a benchtop IVC model.
Overall FilterLength (mm)
Anchor to caudal tail length (mm)
anchor to caudal tail
length
overall�lter
length
501-0000.37_008 IFU, MULTI-LANG, CRUX VENA CAVA FILTER SYSTEM.indd 5 10/22/2014 12:45:04 PM
6
6. Usingatwosheathcoaxialsystem(e.g.6Fx90cmtipinnersheathand10Fx80cmoutersofttipsheath)advancethecoaxialsystemapproximately3mm beyondthetargetedfilterretrievaltail(see Figure 6).7. Advanceandmanipulatethesnareuntiltheretrievaltailiscaptured.Usecaretonotcaptureanchorswithsnare.8. Pulltensiononthesnarewhileadvancing6Fsheathuntiltheretrievaltailhasbeencapturedwithinthe6Finnerretrievalsheath(see Figure 7).9. Keeptensiononthesnarewire,andmovethetorquedeviceagainstthehubofthe6Finnerretrievalsheath.Thislocksthefiltertailinsideofthe6Finner retrievalsheath.10. Whilekeeping6Fsheathandsnaresteady,advance10Fouterretrievalsheathoverfilter(see Figure 8)tocompletelyre-sheaththefilterunder fluoroscopicguidance.WARNING:Useofexcessiveforcetoretrievethefiltercanresultindamagetotheretrievaldevicesand/ordamagetothevenacava.
CAUTION:Avoidpullingfilterintotheoutersheath.11.Removeretrievalsheathsanddevicefrompatient.12. POST RETRIEVAL CARE - After retrieval of filter,standard of care should be followed for removing the sheaths and establishing hemostasis to prevent bleeding at thevascularaccesssite.STORAGE AND HANDLING:Productsshouldbestoredinadry,dark,coolplaceintheiroriginalpackaging.PRODUCT SPECIFICATIONS:Shaftouterdiameter 9FrUsablelength 67cmMaximumguidewire 0.035”
LIMITED WARRANTY:Subjecttotheconditionsandlimitationsonliabilitystatedherein,VolcanoCorporation(“VOLCANO”)warrantsthattheCruxVCF(“theDevice”),assodelivered,shallbefreefromsignificantdefectsinmaterialsandworkmanshipforaperiodofoneyearfromthedateofdelivery.THE SOLE AND EXCLUSIVE REMEDY OF LICENSEE FOR VOLCANO’S BREACH OF THE FOREGOING WARRANTY WILL BE, AT VOLCANO’S OPTION, THE REPAIR OR REPLACEMENT OF A CONFIRMED DEFECTIVE DEVICE. EXCEPT WITH RESPECT TO CONFIRMED DEFECTIVE DEVICES IN BREACH OF THE FOREGOING WARRANTY, VOLCANO CONVEYS NO RIGHT OF RETURN TO LICENSEE AND NO RETURNS WILL BE ACCEPTED. EXCEPT FOR THE FOREGOING WARRANTY, VOLCANO MAKES NO WARRANTY, EXPRESS, IMPLIED OR STATUTORY, AS TO ANY MATTER WHATSOEVER, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT. FURTHER, VOLCANO MAKES NO REPRESENTATIONS REGARDING THE CORRECTNESS, COMPLETENESS, ACCURACY OR RELIABILITY OF THE DEVICE OR ACCOMPANYING DOCUMENTATION. THE FOREGOING WARRANTY APPLIES ONLY IN FAVOR OF LICENSEE WHO IS THE END USER AND ORIGINAL LICENSEE OF THE DEVICE AND IS NOT TRANSFERABLE. RETURN OF DEFECTIVE DEVICES MUST BE MADE ACCORDING TO VOLCANO’S THEN-CURRENT RETURN GOODS AUTHORIZATION PROCEDURES. VOLCANO WILL NOT ACCEPT ANY RETURNS FOR STERILE DEVICES IF THE ORIGINAL PACKAGING HAS BEEN TAMPERED WITH OR OPENED, WITHOUT VOLCANO’S PRIOR APPROVAL. Licensee understands that VOLCANO is notresponsibleforandwillhavenoliabilityforanyitemsoranyservicesprovidedbyanypersonsotherthanVOLCANO.VOLCANOshallhavenoliabilityfordelaysorfailuresbeyonditsreasonablecontrol.Additionally(andwithoutlimitation),,thiswarrantydoesnotapplyif:1.TheDeviceisusedinamannerotherthandescribedbyVOLCANOintheInstructionsForUsesuppliedwiththeDevice.2.TheDeviceisusedinamannerthatisnotinconformancewithpurchasespecificationsorspecificationscontainedintheInstructionsForUse.3.TheDeviceisre-used,reprocessedorre-sterilized.4.TheDeviceisrepaired,altered,ormodifiedbyotherthanVOLCANOauthorizedpersonnelorwithoutVOLCANOauthorization.5.TheDeviceissubjectedtounusualphysical,electricalorenvironmentalstressorisdamagedduringshipmenttoLicensee.LIMITATION OF LIABILITY:VOLCANO’STOTALAGGREGATELIABILITYARISINGOUTOFTHESALEORUSEOFTHEDEVICEWILLBELIMITEDTOTHEAMOUNTOFTHEPURCHASEPRICEFORTHEDEVICEINQUESTION.UNDERNOCIRCUMSTANCESWILLVOLCANOBELIABLEFORANYINCIDENTAL,CONSEQUENTIAL,INDIRECT,EXEMPLARY,PUNITIVEORSPECIALDAMAGES,INCLUDINGDAMAGESFORLOSTREVENUE,PROFITSORBUSINESSOPPORTUNITIES,THECOSTOFPROCUREMENTOFSUBSTITUTEGOODSORSERVICESOROTHERFINANCIALLOSSES.THESELIMITATIONSAPPLYEVENIFVOLCANOHASBEENADVISEDOFTHEPOSSIBILITYOFSUCHDAMAGES,NOTWITHSTANDINGANYFAILUREOFESSENTIALPURPOSEOFANYLIMITEDREMEDYANDREGARDLESSOFTHETHEORYOFLIABILITY.If claimsunder thiswarrantybecomenecessary, contactVOLCANO for instructionsand issuanceofaReturnMaterialAuthorizationnumber if theDEVICE is tobereturned.EquipmentwillnotbeacceptedforwarrantypurposesunlessthereturnhasbeenauthorizedbyVOLCANO.PATENTwww.volcanocorp.com/patents.phpThisproductislicensedtothecustomerforsingleuseonly.CruxisaregisteredtrademarkofVolcanoCorporation.VolcanoandtheVolcanologoaretrademarksofVolcanoCorporationandareregisteredintheUnitedStatesandothercountries.ADDITIONALQUESTIONSREGARDINGTHISPRODUCTSHOULDBEDIRECTEDTO:
501-0000.37/008RevisionDate:10/2014 www.volcanocorp.com
Manufactured By: OrVolcano Corporation2870KilgoreRoadRanchoCordova,CA95670USATelephone:(800)228-4728 (916)638-8008Fax:(916)638-8112
Manufactured For:Volcano Corporation 2870KilgoreRoadRanchoCordova,CA95670USAbyVolcaricaS.R.L.CoyolFreeZoneandBusinessParkBuildingB37Coyol,Alajuela,CostaRicaTelephone:(800)228-4728(916)638-8008Fax:(916)638-8112
Authorized European Representative:VolcanoEuropeBVBA/SPRLExcelsiorlaan41B-1930Zaventem,BelgiumTelephone:+32.2.679.1076Fax:+32.2.679.1079
MR -Conditional
Use Before Date
Do not use open or damaged packages
Content: One (1)
Single Use Only
Do not Re-Sterilize
Prescription Only
Store in a dry, dark, cool place
Sterilized using Ethylene Oxide
Not made with Natural Rubber Latex
Contains phthalate: benzyl butyl phthalate (BBP)
Nonpyrogenic
1
BBP
0086
Figure 8Advance outer retrieval sheath over the �lter
Figure 6Advance the snare 3mm beyond the retrieval tail (Femoral retrieval shown here)
Figure 7Advance the 6F sheathuntil the retrieval tail has been captured
2STERILIZE
EC REP
501-0000.37_008 IFU, MULTI-LANG, CRUX VENA CAVA FILTER SYSTEM.indd 6 10/22/2014 12:45:05 PM
