BEUDAMED
    FDA Adverse Event Death Summary report: N

    FEMORAL RECOVERY FILTER FEMORAL SYSTEM

    MDR report key: 538589 · Received July 30, 2004

    Report

    Report Number
    538589
    Event Type
    Death
    Date Received
    July 30, 2004
    Date of Event
    July 24, 2004
    Report Date
    July 29, 2004
    Manufacturer
    C.R. BARD INC.
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PLACEMENT OF TEMPORARY INFERIOR VENA CAVA FILTER IN THE LOWER INFERIOR VENA CAVA - COMMON ILIAC VEIN JUNCTION IN 2004 DUE TO DEEP VENOUS THROMBOSIS, MASSIVE PULMONARY EMBOLISM. A BARD RECOVERY RETRIEVABLE INFERIOR VENA CAVA FILTER WAS DEPLOYED SUCCESSFULLY IN A HIGH INFRARENAL LOCATION. DIGITAL RADIOGRAPH WAS PERFORMED TO CONFIRM PLACEMENT. TWO DAYS LATER, COUNTY CORONER NOTIFED THIS FACILITY THAT THE PT EXPIRED. ON AUTOPSY, THE FILTER WAS FOUND AT THE ROOT OF THE PULMONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL RECOVERY FILTER FEMORAL SYSTEM TEMPORARY IVC FILTER DTK C.R. BARD INC. * GF0E2524

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death