safety communications _ removing retrievable inferior vena cava filters_ initial communication

03/08/2015 SafetyCommunications>RemovingRetrievableInferiorVenaCavaFilters:InitialCommunication

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm 1/3

U.S.FoodandDrugAdministrationProtectingandPromotingYourHealth

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RemovingRetrievableInferiorVenaCavaFilters:InitialCommunication

FDAissuedanupdatedsafetycommunication(/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm)onMay6,2014.

DateIssued:August09,2010

Audience:Forimplantingphysiciansandcliniciansresponsiblefortheongoingcareofpatientswithinferiorvenacava(IVC)filters.Includesinterventionalradiologists,interventionalcardiologists,vascularsurgeons,emergencyroomphysicians(trauma),bariatricsurgeons,orthopedicsurgeons,primarycarephysicians

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03/08/2015 SafetyCommunications>RemovingRetrievableInferiorVenaCavaFilters:InitialCommunication

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm 2/3

Device:

IVCfiltersaresmall,cagelikedevicesthatareinsertedintotheinferiorvenacava(themainvesselreturningbloodfromthelowerhalfofthebodytotheheart)tocapturebloodclotsandpreventthemfromreachingthelungs.IVCfiltersarefrequentlyplacedinpatientsatriskforpulmonaryembolism(abloodclotinthelungs)whenanticoagulanttherapycannotbeusedorisineffective.SomepatientsmayrequirelongtermprotectionfromPE,andimplantationofpermanentIVCfiltersisoftenperformedinthesecases.Othersonlyrequireshorttermprotection,inwhichcaseretrievableIVCfiltersaretypicallyused,asthesedeviceshavetheoptiontoberemovedoncethepatientsriskofPEsubsides.

SummaryofProblemandScope:

IVCfilterusagehasincreasedrapidlyduringthepastthirtyyears.In1979,2,000IVCfilterswereused,whilein2007,almost167,000filterswereimplanted,andthemarketforIVCfiltersisonlyexpectedtoincrease,withanestimated259,000IVCfilterstobedeployedin2012(SmouseandJohar,EndovascularToday,February2010).

Since2005,theFDAhasreceived921deviceadverseeventreportsinvolvingIVCfilters,ofwhich328involveddevicemigration,146involvedembolizations(detachmentofdevicecomponents),70involvedperforationoftheIVC,and56involvedfilterfracture.Someoftheseeventsledtoadverseclinicaloutcomesinpatients.Thesetypesofeventsmayberelatedtoaretrievablefilterremaininginthebodyforlongperiodsoftime,beyondthetimewhentheriskofPEhassubsided.

TheFDAisconcernedthattheseretrievableIVCfilters,intendedforshorttermplacement,arenotalwaysremovedonceapatientsriskforPEsubsides.KnownlongtermrisksassociatedwithIVCfiltersincludebutarenotlimitedtolowerlimbdeepveinthrombosis(DVT),filterfracture,filtermigration,filterembolizationandIVCperforation.

Recommendations/Actions:

FDArecommendsthatimplantingphysiciansandcliniciansresponsiblefortheongoingcareofpatientswithretrievableIVCfiltersconsiderremovingthefilterassoonasprotectionfromPEisnolongerneeded.

FDAencouragesallphysiciansinvolvedinthetreatmentandfollowupofIVCfilterrecipientstoconsidertherisksandbenefitsoffilterremovalforeachpatient.IfapatienthasaretrievableIVCfilterthatshouldberemovedbasedonhisorherindividualrisk/benefitprofile,theprimarycarephysicianand/orthoseprovidingongoingpatientcareshouldreferthepatientforIVCfilterremovalwhenfeasibleandclinicallyindicated.

03/08/2015 SafetyCommunications>RemovingRetrievableInferiorVenaCavaFilters:InitialCommunication

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm 3/3

FDAActivities:

ThisinitialcommunicationisinkeepingwithFDAscommitmenttoinformthepublicaboutemergingdevicesafetyissues.TheAgencywillcommunicateitsfinalconclusionswhentheanalysisofavailabledataiscomplete.

Aspartofdevelopingourfinalposition,FDAreviewedtheliteratureandisconductingquantitativedecisionanalysismodelingtoevaluatethechangeintherisk/benefitprofileafterretrievableIVCfilterimplantationovertime.MoreinformationaboutFDAsdecisionanalysismodelincludingrisk/benefitimplantationtimeframesuggestionswillbemadeavailableinanupdatetothiscommunicationaswellasinafuturepublicationinapeerreviewedmedicaljournal.

ContactInformation:

Ifyouhavequestionsaboutthiscommunication,pleasecontacttheDivisionofSmallManufacturers,InternationalandConsumerAssistance(DSMICA)atDSMICA@cdrh.fda.gov(mailto:DSMICA@cdrh.fda.gov)or8006382041.

ThisdocumentreflectsFDAscurrentanalysisofavailableinformation,inkeepingwithourcommitmenttoinformthepublicaboutongoingsafetyreviewsofmedicaldevices.

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