CRUX® VENA CAVA FILTER (VCF) ENGLISH - · PDF file2 CRUX® VENA CAVA FILTER (VCF)...
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2 ENGLISH CRUX® VENA CAVA FILTER (VCF) 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 guidewires 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 wireforms and features cranial and caudal retrieval tails. Each retrieval tail has an atraumatic tip and a radiopaque tantalum marker band to facilitate visualization during retrieval. Five tissue anchors (2 cranial and 3 caudal) are attached to the wireforms.The clot trapping portion of the filter is formed from a web of ePTFE filaments attached to the wireforms using PTFE/FEP tubing.The CruxVCF comes in two pre-loaded configurations for delivery of the filter by a femoral approach or a jugular approach. See Figure 1 and Figure 2 for further detail about the product. The delivery catheter for the Crux VCF is a disposable, 9Fr introducer-sheath-compatible, single-use device (see Figure 2). It is an 0.035” guidewire-compatible over-the-wire catheter and consists of a polycarbonate inner shaft and a nylon outer shaft.The inner shaft consists of the guidewire lumen and a flexible, radiopaque tracking tip. The outer shaft has a radiopaque distal marker band, a Touhy-Borst hemostasis valve and a one-way check valve for flushing. The filter can be retrieved using commercially available snares and sheaths. CONTRAINDICATIONS: Filter Placement • Average or Max Diameter of the IVC > 28 mm • Diameter of the IVC < 17 mm • Vena cava filters should not be implanted in patients with risk of septic embolism Optional Filter Retrieval • Retrieval of the filter with significant thrombus in or near the filter • Retrieval of the filter for patients with an ongoing high risk for pulmonary embolism. WARNINGS: Filter Placement • Do not deploy the filter unless the IVC has been properly measured using imaging. • The CruxVCF consists of nickel-titanium alloy which is generally considered safe. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. • All device manipulations should be under fluoroscopic guidance. Never advance or manipulate the devices or any accessories during deployment or retrieval without fluoroscopic guidance. Outer Shaft Handle Outer Shaft Tracking Tip Check Valve Outer Shaft Flush Port Inner Shaft Guidewire Port (.035”) Hemostasis Valve Inner Shaft 12 cm 501-0100.251/001 Figure 2 67 cm 9 Fr Trailing Marker Band Leading Marker Band
Transcript of CRUX® VENA CAVA FILTER (VCF) ENGLISH - · PDF file2 CRUX® VENA CAVA FILTER (VCF)...
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ENGLISHCRUX® VENA CAVA FILTER (VCF)
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-expandingnitinolwireformsandfeaturescranialandcaudalretrievaltails.Eachretrievaltailhasanatraumatictipandaradiopaquetantalummarkerbandtofacilitatevisualizationduringretrieval.Fivetissueanchors(2cranialand3caudal)areattachedtothewireforms.TheclottrappingportionofthefilterisformedfromawebofePTFEfilamentsattachedtothewireformsusingPTFE/FEPtubing.TheCruxVCFcomesintwopre-loadedconfigurationsfordeliveryofthefilterbyafemoralapproachorajugularapproach.See Figure 1 and Figure 2 forfurtherdetailabouttheproduct.Thedeliverycatheter for theCruxVCF isadisposable,9Fr introducer-sheath-compatible, single-usedevice (see Figure 2). It isan0.035”guidewire-compatibleover-the-wirecatheterandconsistsofapolycarbonateinnershaftandanylonoutershaft.Theinnershaftconsistsoftheguidewirelumenandaflexible,radiopaquetrackingtip.Theoutershafthasaradiopaquedistalmarkerband,aTouhy-Borsthemostasisvalveandaone-waycheckvalveforflushing.Thefiltercanberetrievedusingcommerciallyavailablesnaresandsheaths.
CONTRAINDICATIONS:Filter Placement • AverageorMaxDiameteroftheIVC>28mm • DiameteroftheIVC<17mm • VenacavafiltersshouldnotbeimplantedinpatientswithriskofsepticembolismOptional Filter Retrieval • Retrievalofthefilterwithsignificantthrombusinornearthefilter • Retrievalofthefilterforpatientswithanongoinghighriskforpulmonaryembolism.
WARNINGS:Filter Placement • DonotdeploythefilterunlesstheIVChasbeenproperlymeasuredusingimaging. • TheCruxVCFconsistsofnickel-titaniumalloywhichisgenerallyconsideredsafe.Patientswhoareallergictonickelmayhaveanallergicreactiontothisdevice, especiallythosewithahistoryofmetalallergies. • Alldevicemanipulationsshouldbeunderfluoroscopicguidance.Neveradvanceormanipulatethedevicesoranyaccessoriesduringdeploymentorretrieval withoutfluoroscopicguidance.
Outer Shaft HandleOuter ShaftTracking Tip
Check Valve
Outer Shaft Flush Port
Inner ShaftGuidewire Port (.035”)
Hemostasis Valve
Inner Shaft
12 cm
501-0100.251/001Figure 2
67 cm
9 Fr
Trailing Marker Band
LeadingMarker Band
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• Excessiveforceshouldnotbeusedtoplacethefilter. • TheCruxVCFisonlyintendedforfilterdeliveryviathefemoralorjugularapproach. • Donotattempttodeliverthefilteriflargethrombusispresentattargeteddeliverysite. • Donotreuse,re-sterilizeorreprocess.Impairmentofstructuralintegrityorfunctionmayresultfromreuse,re-sterilizationorreprocessingofthedevice, possiblyleadingtoadversepatientreactions. • Thefiltermaybepositionedpriortodrawingbacktheoutershaftorwithonlythefirstretrievaltailreleasedfromtheoutershaft.Donotattempttoreposition orre-sheaththefilteronceyouhavepassedthispoint. • Filterfracturesareaknowncomplicationofvenacavafilters.Therehavebeenreportsofseriouspulmonaryandcardiaccomplicationswithvenacavafilters requiringtheretrievalofthefragmentutilizingendovascularandorsurgicaltechniques. • Themovement,migrationand/ortiltareknowncomplicationsofvenacavafilters.Migrationoffilterstotheheartorlungshasbeenreported.Therehavealso been reports of caudal filtermigration.Migrationmay be caused by placement in IVCswith diameters exceeding the dimensions specified in the IFU. Migrationmayalsobecausedbyimproperdeployment,deploymentintoclotsand/ordislodgementduetolargeclotburdens. • ImplantingoftheCruxVCFcanbedonebyeithertheFemoral(REF7024)orJugular(REF7025)approach.Ensureyouselectthecorrectproductforthe intendedapproach. • Donotdisassemblethedevice.Ifanycomponentsaredisassembled,donotreassemblefordeployment. • Afteruse,theCruxVCFandaccessoriesshouldbetreatedasabiohazard.Handleanddisposeofinaccordancewithacceptedmedicalpracticeandapplicable localstateandfederallawsandregulations.Optional Filter Retrieval • Excessiveforceshouldnotbeusedtoretrievethefilter. • DonotremovetheCruxVCFifthrombusistrappedwithinthefilter. • Afterfilterimplantation,anycatheterizationprocedurerequiringpassageofadevicemaybeimpeded.
PRECAUTIONS: • Possibleallergicreactionsshouldbeconsidered.Theproductisintendedforusebyphysicianstrainedandexperiencedindiagnosticandinterventional techniques. • ThedecisiontouseanyIVCfiltermustultimatelybemadebythephysicianonanindividualpatientbasis. • Standardtechniquesforplacementofvascularaccesssheaths,angiographiccathetersandguidewiresshouldbeemployed.Filter Placement • TheCruxVCFisspecificforafemoralorjugularveinapproach. • Maintainguidewireposition,withanatraumatic,non-J guidewire tip preceding the delivery catheter while advancing. • Ifthefilterisdeployedinanincorrectpositionororientation, consider immediate retrieval using the Optional Filter Retrievalprocedures.Donotrepositionadeployedfilter. • The filtermay foreshorten as it is deployed. Consider this whenpositioningthefilterduringthedeploymentprocedure. For reference only see Table 1. • Anatomicalvariancesmaycomplicatefilterinsertionand deployment. • Donotabortdeploymentorre-sheathoncefilter deploymenthasbeeninitiated.Optional Filter Retrieval • Aninferiorvenacavagramevaluationforthrombusshouldbeperformedpriortoattemptedretrieval. • Donotattemptretrievalifthrombusispresentinthefilterand/orcaudaltothefilter. • Neverredeployaretrievedfilter. • Anatomicalvariancesmaycomplicatetheremovalprocedure. • Thedecisiontoremoveafiltershouldbebasedonthepatient’sindividualrisk/benefitprofile.Retrievethefilterassoonasfeasibleandclinicallyindicated.NOTE: The safety and effectiveness of the Crux VCF has been established for the cohort studied under the clinical investigation and has not been established for pediatricpatients,pregnantfemalesorforsuprarenalplacement.
StandardandguidelinesdevelopedbytheSocietyofInterventionalRadiologyrecommendthatpatientswithfilters,permanentorretrievable,aretrackedandshouldreceive followupvisits subsequent to theplacementof thefilter. FDA recommends that implantingphysicians responsible for theongoingcareofpatientswithretrievableIVCfiltersshouldconsiderremovingthefilterassoonasitisnolongerneeded.FDAencouragesallphysiciansinvolvedinthetreatmentandcareofIVCfilterrecipientstoconsidertherisksandbenefitsoffilterremovalforeachpatient.SOURCE: • ReportingStandardforInferiorVenaCavaFilterPlacementandPatientFollow-upSupplementforTemporaryandRetrievable/OptionalFilters.Millward,S., etal.:J.VascIntervRadiol2005;16:441-443 • 2012AmericanCollegeofRadiologyACRAppropriatenessCriteria® • TheParticipantsintheVenaCavaFilterConsensusConference:JVascInterRadiol2003;14:S427-S432 • Drew M. Caplin, et. al., Quality Improvement Guidelines for the Performance of InferiorVena Cava Filter Placement for the Prevention of Pulmonary Embolism.J.VascIntervRadiol2011;22:1499–1506HOW SUPPLIED: • TheCruxVCFissterilizedusingethyleneoxidegasinpeel-openpackages,andisnon-pyrogenic. • TheCruxVCFissterileifpackageisunopenedandundamaged.
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
Table 1- Estimated deployment length is derived from a benchtop IVC model
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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 HeatingIn non-clinical testing with body coil excitation, the Crux vena cava filter produced a maximal differential temperature rise of 4.5°C at a maximumspecific absorption rate (SAR) of 3.4W/kg for 15 minutes of scanning in a 3.0-Tesla MR system (Siemens Trio, SYNGO MR A30 4VA30A software, Munich,Germany). Scaling of the SAR and observed heating indicates that a SAR of 2 W/kg would be expected to yield a localized temperature rise of 2.6°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.
POTENTIAL ADVERSE EVENTS:Afullexplanationoftherisksandbenefitsshouldbediscussedwitheachprospectivepatientpriortoimplantation.Adverseeffectsrangefrommildtoserious.Seriousadverseeffects,sometimesleadingtosurgicalinterventionordeath,havebeenassociatedwiththeuseofIVCfilters.Inaddition,complicationsduetoindividualpatientreactiontoanimplanteddevice,ortophysicalorchemicalchangesinthecomponents,maynecessitatereoperationandreplacementofthefilter.PossibleadverseeffectsassociatedwithIVCfiltersinclude,butarenotlimitedto,thefollowing:arrhythmia,arteriovenousfistula,backorabdominalpain,contrastmediaextravasationattimeofvenacavogram,death,deepveinthrombosis,deliverysystemdetachmentorembolization,emboli(air,thromboticortissue),filterexpansionfailure,filterordeviceentanglement,fever,filterfracture,filterthrombosisorocclusion,filtermalpositioned,mis-orientedorcompressed,filtermigration,filter embolization,guidewire entrapment , hematomaornerve injury at thepuncture siteor subsequent retrieval site,hemorrhagewithorwithout transfusion,hemothorax,inabilitytoretrievefilter,infection,intimaltear,occlusionofsmallvessels,organinjury,painordiscomfort,perforationorotheracuteorchronicdamageoftheIVCwall,phlegmasiaceruleandolens,phneumothorax,postphlebitissyndrome,pulmonaryembolism(recurrentornew),renalinjuryorfailure,restrictionofbloodflow,stenosisatimplantsite,stroke,thrombosis,venousulceration,vesseldissection,perforation,ulcerationorrupture,vesselspasm.
CLINICAL STUDIES:Amultinationalinvestigationalstudywasconductedtoassessthesafety,performanceandeffectivenessoftheCruxVCFasbothretrievableandpermanentdevice. Thestudywasaprospectivesingle-armcomparingtheresultstoapre-establishedperformancegoal.TheprimaryendpointwasClinicalSuccessdefinedasacompositeof technicalsuccess,and freedomfrompulmonaryembolism,migrationoradevice relatedadverseevent requiring intervention. ThestudyhypothesisofClinicalSuccesswouldbemetifthelowerlimitoftheone-sided95%confidenceintervalwasnotbelow80%.Secondaryendpointsincludedretrievalsuccess,migration,IVCF
thrombusanddeviceintegrity.Onehundred and twenty-five (125) subjects at high risk for pulmonary embolism(PE)wereenrolled.Ofthe125,73(58%)maleand52(42%)femalewereincludedwithameanageof59.6±17.2. Theprimarythreereasonsforfilter implantweresurgical risk(36%),presenceofDVT(15%)andcontraindicationtoanticoagulation(14%).Thefourprimarythromboembolicriskfactorswereoverall,thromboembolicrisk factors DVT at baseline (58.4%), history of DVT (49.6%), contraindication toanticoagulation (37.6%)andhistoryofPE (36.8%). All subjectshadoneormorethromboembolicriskfactors.Filter deployment technical success occurred in123/125 (98%). In two cases, thephysicianschoosetoretrievethefilterimmediatelybecauseofinaccuratedeployment
andreplacewithcommerciallyavailablefilters.Therewerenoadverseclinicalsequelaeinthosetwosubjects.Fifty three (53) of 54 patients had their filter successfully retrieved.Theaveragetimetoretrievalwas85±58days(see Figure 3).One(1)filtercouldbenotretrievedat167daysduetoexcessiveforce.Afemoralretrievalapproachwasusedin37procedures(70%).RetrievalSuccess was achieved in 98% with only 1 radiographic anomalyobservedatretrievalwithnoclinicalsequelae.Forty-nine(49)subjectscompletedthestudywithapermanentfilterinsituat180days. Twenty-two,(16%)didnotcompletethestudy:14(11%)patientsdiedduetopre-existingorotherreasonsunrelatedto the study, 6 (5%) subjects withdrew and 2 (<2%)were lost tofollowup.Nopatientdeathswereattributedtothefilter,deploymentor retrieval procedures based on independent Medical Monitoradjudication.During the course of the study, no embolization, migration orfractures were observed. Three subjects had pulmonary embolisms
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
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
<_
Figure 3 - Filter Time from Implantation to Retrieval. Average time to retrieval was 85 ± 58 days.
TABLE 2 - Subject Accountability for the Crux Vena Cava Filter Study
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(2.4%),confirmedbyCTorperfusionlungscan,and17subjectshadnewDVT(14%).Therewere8subjectswiththrombusobservedinornearthefilter(6%),primarilyatretrievalevaluations,nosubjectsweresymptomatic.TheprimaryendpointofClinicalSuccesswas96.0%(91.8%lowerone-sided95%CLexceedingthe80%LowerLimit).Retrievalsuccesswas53/54(98%)averagetimetoretrievalwas85+58dayswith1radiographicanomalyobservedwithnoclinicalsequelae.Theclinicaltrialdemonstratedthesafedeployment,implantandretrievalofthefilter.Technicalandretrievalsuccessareshowntobehigh,withalowrateofdevicerelatedcomplications.Theobservedratesoffiltermigrationandpulmonaryembolizationwereconsistentwithpublishedliterature.Foradditionalinformationonsubjectdisposition(see Table 2).
INSTRUCTIONS FOR USE:For Deployment • Standardmicro-puncturesetorseldingerneedletoobtain percutaneous access • 9Fshortintroducersheathifdesired • 0.035”(outerdiameter)guidewirewithaminimumlengthof180cm • Angiographiccatheter
Preparing the Crux VCF (Femoral REF 7024 or Jugular REF 7025) for the filter implantation procedure.
Inspection Prior to UseCarefullyinspectthepackagepriortouseforanybreachofthesterilebarrierordamagetothecontents.Ifthesterilebarrierintegrityiscompromisedorthecontentsdamaged,donotuseandcontactyourVolcanoCorporationrepresentative.Preparation For Use1. Openouterpouchattheguidewireportend,andtransfertheinnerpouchanddevicetosterilefieldusingaseptictechnique.2. Opentheinnerpouchattheguidewireportend,andremovedevicefrompouch.3. Removethestyletfromthedistaltipofthedeliverycatheteranddiscard.
6. Fastencheckvalvetooutershaftflushport.
NOTE: All catheter or Crux VCF manipulations should be done while using fluoroscopy imaging guidance.9. Accesseitherthefemoralorjugularveinusingstandardpercutaneoustechnique.10. Placea0.035”straighttippedguidewireintotheveinandadvancetotargetsite.11. Advanceamulti-sideholeangiographiccatheterandremovetheguidewiretoperformdiagnosticimagingofthevenacavausingacontrastinjection.Locate therenalveinsandconfirmthatthevenacavadiameterandanatomyareappropriateforIVCfilterplacement.NOTE: Diagnostic imaging of the vena cava can also be performed via the Crux VCF Delivery Catheter. If this is done, the contrast injection should take place through the guidewire lumen of the delivery catheter. Contrast may come through the check valve if a stopcock or other device is not placed over it. WARNING: Do not exceed maximum pressure rating of 500 psi and flow rate of 10 ml per second. 12. Proceedwithdeployment if the IVC target sitemeasures17mmto28mmat itswidestor averagediameter. For referenceonly, estimatesofdeployedfilter length are provided in Table 1.13. Re-insertguidewireintotheangiographiccatheterandremovethecatheter,leavingguidewireinplace.14. UsingtheCruxVCFdeliverycatheterindicatedfortheintendedapproach(FemoralREF7024orJugularREF7025),verifythatthehemostasisvalveontheouter shafthandleistight.
4. CarefullyremovetheCruxVCFfromthe insert card and inspect the device for damage.WARNING: Donotusethedeviceifanydamageexistsonthedevice.5. Tighten the hemostasis valve on the outershafthandle.
7. Usingnormalsterileheparinizedsaline,flushtheoutershaftlumen throughthehandleflushportwhileoccludingtheinnershaftguidewire port.Verifythattheflushisobservedexitingthedistalendoftheouter shaftofthedeliverycatheter.
8. Using normal sterile heparinized saline, flush the guidewire lumen through the guidewire port. Verify that the flush is observed exiting the distal end of the tracking tip of the delivery catheter.
For Retrieval • Standardmicro-puncturesetorseldingerneedleto obtain percutaneous access • 0.035”(outerdiameter)guidewirewithaminimumlengthof180cm • Angiographiccatheter • 6Fx90cmtipsheath • 10Fx80cmtipsheath
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15. Loadandadvancethedeliverycatheterovertheguidewireunderfluoroscopicguidanceto thetargetsite.16. Withtheouterflushportofthedeliverycatheterpointedinthe12o’clockposition, usingfluoroscopicguidance: a. Femoral approach-positiontheleadingradiopaquemarkerband4cmabove thelowestrenalvein.Ensurethatthecranialanchorsareinfrarenal post-deployment. b. Jugular approach-positionthetrailingradiopaquemarkerband3cmabove thelowestrenalvein.Ensurethatthecranialanchorsareinfrarenalpost- deployment.17. VerifytheCruxVCFdeliverycatheterpositioningintheinferiorvenacavaandmake adjustmentsasnecessary.18. Loosenthehemostasisvalve.
CAUTION:Avoidrotatingtheoutershafthandleduringshaftpullbackasthiscanresultinaninaccuratedeployment.20. Untiltissueanchorsareunsheathed,itispossibletostopandre-positionthedeliverycatheterduringdeployment.Neverattempttore-sheaththefilter.CAUTION:Thefiltermayforeshortenasitisdeployed: • Femoral Approach: thecranialfiltertailmaylandup to 1.5cmcaudaltotheinitialdeploymentlocation. • Jugular Approach: the cranial tail may land up to 0.5cmcaudaltotheinitialdeploymentlocation.21. Continuepullingbacktheoutershafthandleuntilthehemostasisvalvecontactsthedistaledgeoftheguidewireport.Ensurethathemostasisvalveispulled completelybacktoallowfulldeploymentofthefilter.
NOTE: The Crux VCF will fully deploy and release from the delivery catheter once the hemostasis valvecontactsthedistaledgeoftheguidewireport.CAUTION: Donotattempttore-positionadeployedfilter.22. VerifyCruxVCFpositioningintheinferiorvenacava.
23. Tightenthehemostasisvalve.
Removal of the Delivery System Post Deployment1. Ensurethehemostasisvalvehasbeentightened.2. Usingfluoroscopy,ensurethetrackingtipisnotseatedagainsttheoutershafttoprevent possiblefilterdisplacement.3. Removethedeliverycatheterfromthepatientsuchthatthetipiscarefullypulledthroughthe deployedfilter.
CAUTION:Ensurethatthedeliverycatheterdoesnotinteractwiththedeployedfilterduringwithdrawal,topreventshiftingofthefilter.4. Afterdeploymentoffilter,standardofcareshouldbefollowedforremovalofdevicesandestablishinghemostasistopreventbleedingatthevascularaccesssite.Optional Retrieval of the Crux VCFNOTE: RetrievaloftheCruxVCFcanbeaccomplishedviaeitherthefemoralveinorthejugularvein.1. Accesseitherthefemoralorjugularveinusingstandardpercutaneoustechnique.2. Placea0.035”guidewireintotheveinandadvancetotargetsite.3. Advanceanangiographic catheterovertheguidewiretothetargetsite.Removeguidewirefromangiographiccatheter.4. PerformavenacavagramoftheIVCandfilterforthrombus.5. Reinsertguidewireintotheangiographiccatheter.Removetheangiographiccatheter,leavingtheguidewireinplace.6. Usingatwosheath/cathetercoaxialsystem(e.g.6Fx90cmtipinnersheathand10Fx80cmoutersofttipsheath)advancethecoaxialsystemapproximately3 mmbeyondthetargetedfilterretrievaltail(see Figure 4).7. Advanceandmanipulatethesnareuntiltheretrievaltailis captured.Usecaretonotcaptureanchorswithsnare.8. Pulltensiononthesnarewhileadvancing6Fsheathuntilthe retrievaltailhasbeencapturedwithinthe6Finnerretrievalsheath (see Figure 5).9. Keeptensiononthesnarewire,andmovethetorquedeviceagainst thehubofthe6Finnerretrievalsheath.Thislocksthefiltertail insideofthe6Finnerretrievalsheath.10. Whilekeeping6Fsheathandsnaresteady,advance10Fouter retrievalsheathoverfilter(see Figure 6) to completely re-sheath thefilterunderfluoroscopicguidance.
19. Maintainpositionofthe innershaftsteady,andslowly pull back on the outer shaft handletoinitiatedeployment.CAUTION: Donotpushthe outer sheath back over a partially deployedfilter.
Figure 6Advance outer retrieval sheath over the �lter
Figure 4Advance the snare 3mm beyond the retrieval tail (Femoral retrieval shown here)
Figure 5Advance the 6F sheathuntil the retrieval tail has been captured
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WARNING: Useofexcessiveforcetoretrievethefiltercanresultindamagetotheretrievaldevicesand/ordamagetothevenacava.CAUTION: Avoidpullingfilterintotheoutersheath.11. Removeretrievalsheathsanddevicefrompatient.12. POST RETRIEVAL CARE -Afterretrievaloffilter,standardofcareshouldbefollowedforremovingthesheathsandestablishinghemostasistopreventbleeding atthevascularaccesssite.
STORAGE AND HANDLING:Productsshouldbestoredinadry,dark,coolplaceintheiroriginalpackaging.
PRODUCT SPECIFICATIONS:Shaftouterdiameter 9FrUsablelength 67cmMaximumguidewire 0.035”
LIMITED WARRANTY:Subjecttotheconditionsandlimitationsonliabilitystatedherein,VOLCANOCorporation(“VOLCANO”)warrantsthattheCruxVCF(the“Device”),assodelivered,shallbefreefromsignificantmanufacturingdefectsinmaterialsandworkmanshipduringVOLCANO’sstandardmanufacturer’swarrantyperiod.THESOLEANDEXCLUSIVEREMEDYOFLICENSEEFORVOLCANO’SBREACHOFTHEFOREGOINGWARRANTYWILLBE,ATVOLCANO’SOPTION,THEREPAIRORREPLACEMENTOFACONFIRMEDDEFECTIVEDEVICE.EXCEPTWITHRESPECTTOCONFIRMEDDEFECTIVEDEVICESINBREACHOFTHEFOREGOINGWARRANTY,VOLCANOCONVEYSNORIGHTOFRETURNTOLICENSEEANDNORETURNSWILLBEACCEPTED.EXCEPTFORTHEFOREGOINGWARRANTY,VOLCANOMAKESNOWARRANTY,EXPRESS,IMPLIEDORSTATUTORY,ASTOANYMATTERWHATSOEVER,INCLUDINGANYWARRANTYOFMERCHANTABILITY,FITNESSFORAPARTICULARPURPOSEORNON-INFRINGEMENT.FURTHER,VOLCANOMAKESNOREPRESENTATIONSREGARDINGTHECORRECTNESS,COMPLETENESS,ACCURACYORRELIABILITYOFTHEDEVICEORACCOMPANYINGDOCUMENTATION.THEFOREGOINGWARRANTYAPPLIESONLYINFAVOROFLICENSEEWHOISTHEENDUSERANDORIGINALLICENSEEOFTHEDEVICEANDISNOTTRANSFERABLE.RETURNOFDEFECTIVEDEVICESMUSTBEMADEACCORDINGTOVOLCANO’STHEN-CURRENTRETURNGOODSAUTHORIZATIONPROCEDURES.VOLCANOWILLNOTACCEPTANYRETURNSFORSTERILEDEVICESIFTHEORIGINALPACKAGINGHASBEENTAMPEREDWITHOROPENEDWITHOUTVOLCANO’SPRIORAPPROVAL.LicenseeunderstandsthatVOLCANOisnotresponsibleforandwillhavenoliabilityforanyitemsoranyservicesprovidedbyanypersonsotherthanVOLCANO.VOLCANOshallhavenoliabilityfordelaysorfailuresbeyonditsreasonablecontrol.Additionally(andwithoutlimitation),thiswarrantydoesnotapplyif:1. TheDeviceisusedbyunauthorizedorimproperlytrainedpersonnel,orisusedinamannerotherthandescribedbyVOLCANOintheInstructionsForUsesupplied withtheDevice.2. TheDeviceisusedinamannerthatisnotinconformancewithpurchasespecificationsorspecificationscontainedintheInstructionsForUse.3. TheDeviceisre-used,re-processed,repackaged,re-sterilizedorusedafteritsexpirationdate.4. TheDeviceisrepaired,altered,ormodifiedbyotherthanVOLCANOauthorizedpersonnelorwithoutVOLCANO’sexpresswrittenauthorization.5. TheDeviceissubjectedtounusualphysical,electricalorenvironmentalstressorisdamagedduringshipmenttoLicensee.
LIMITATION OF LIABILITY:VOLCANO’STOTALAGGREGATELIABILITYARISINGOUTOFTHESALEORUSEOFTHEDEVICEWILLBELIMITEDTOTHEAMOUNTOFTHEPURCHASEPRICEFORTHEDEVICEINQUESTION.UNDERNOCIRCUMSTANCESWILLVOLCANOBELIABLEFORANYINCIDENTAL,CONSEQUENTIAL,INDIRECT,EXEMPLARY,PUNITIVEORSPECIALDAMAGES,INCLUDINGDAMAGESFORLOSTREVENUE,PROFITSORBUSINESSOPPORTUNITIES,THECOSTOFPROCUREMENTOFSUBSTITUTEGOODSORSERVICESOROTHERFINANCIALLOSSES.THESELIMITATIONSAPPLYEVENIFVOLCANOHASBEENADVISEDOFTHEPOSSIBILITYOFSUCHDAMAGES,NOTWITHSTANDINGANYFAILUREOFESSENTIALPURPOSEOFANYLIMITEDREMEDYANDREGARDLESSOFTHETHEORYOFLIABILITY.Ifclaimsunderthiswarrantybecomenecessary,contactVOLCANOforinstructionsandissuanceofaReturnMaterialAuthorizationnumberiftheDeviceistobereturned.EquipmentwillnotbeacceptedforwarrantypurposesunlessthereturnhasbeenauthorizedbyVOLCANO.PATENTwww.volcanocorp.com/patents.phpThisproductislicensedtothecustomerforsingleuseonly.CruxisaregisteredtrademarkofVolcanoCorporation.VolcanoandtheVolcanologoaretrademarksofVolcanoCorporationandareregisteredintheUnitedStatesandothercountries.ADDITIONALQUESTIONSREGARDINGTHISPRODUCTSHOULDBEDIRECTEDTO:
501-0000.57/002RevisionDate:01/2016
Legal Manufacturer:Volcano Corporation2870KilgoreRoadRanchoCordova,CA95670USATelephone:(800)228-4728 (916)638-8008Fax:(916)638-8112
Manufacturing Sites:Volcano Corporation 2870KilgoreRoadRanchoCordova,CA95670USAOrVolcaricaS.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
www.volcanocorp.com
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
2STERILIZE
0086
EC REP
