BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD IVC FILTER

    MDR report key: 861117 · Received May 31, 2007

    Report

    Report Number
    MW5002449
    Event Type
    Injury
    Date Received
    May 31, 2007
    Date of Event
    May 24, 2007
    Report Date
    May 31, 2007
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A BARD IVC FILTER WAS INSERTED ON THE PT IN 2007. THE PHYSICIAN PLANNED ON REMOVING THIS FILTER SEVENTEEN DAYS LATER. PRIOR TO REMOVAL OF THIS FILTER, A VENOGRAM WAS OBTAINED. THE VENOGRAM SHOWED THE FILTER HAD DISLODGED INFERIORLY APPROXIMATELY 4 CM IN THE IVC. FIVE OF THE LIMBS OF THE IVC FILTER APPEARED TO PERFORATE THE IVC MEDIALLY AND TWO OF THE LEGS ARE APPROACHING THE LUMEN OF THE THIRD PORTION OF THE DUODENUM, ONE OF WHICH MAY BE ACTUALLY BE IN THE LUMEN OF THE DUODENUM. THE DECISION WAS MADE NOT TO ATTEMPT TO REMOVE THE FILTER AND CONTINUE TO OBSERVE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD IVC FILTER IVC FILTER DTK BARD MEDICAL DIVISION BARD G2 FILTER 6FPL3117

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other