safety communications _ removing retrievable inferior vena cava filters_ initial communication
DESCRIPTION
Removing Retrievable Inferior Vena Cava Filters: Initial CommunicationTRANSCRIPT
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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.
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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)[email protected](mailto:[email protected])or8006382041.
ThisdocumentreflectsFDAscurrentanalysisofavailableinformation,inkeepingwithourcommitmenttoinformthepublicaboutongoingsafetyreviewsofmedicaldevices.
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