BEUDAMED
    FDA Adverse Event Death Summary report: N

    G2 FILTER SYSTEM-FEMORAL

    MDR report key: 1240468 · Received November 20, 2008

    Report

    Report Number
    2020394-2008-00338
    Event Type
    Death
    Date Received
    November 20, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS MFG LOT NUMBER. THE REPORTED CAUSE OF DEATH WAS PULMONARY EMBOLI. BASED ON THE INFO RECEIVED, IT IS UNK IF THE CLOT OCCURRED PRIOR TO FILTER PLACEMENT OR IF IT WENT THROUGH THE FILTER, ORIGINATED ABOVE THE FILTER, OR FROM COLLATERAL VESSELS. THE RESULT OF THE INVESTIGATION WAS INCONCLUSIVE. THE CURRENT IFU (INSTRUCTIONS FOR USE) FOR THIS DEVICE STATES: COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POTENTIAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: MIGRATION. MOVEMENT OR MIGRATION OF THE FILTER IS A KNOWN COMPLICATION OF VENA CAVA FILTERS. THIS MAY BE CAUSED BY PLACEMENT IN IVCS WITH DIAMETERS EXCEEDING THE APPROPRIATE LABEL DIMENSIONS SPECIFIED IN THE IFU. ACUTE OR RECURRENT PULMONARY EMBOLISM. THIS HAS BEEN REPORTED DESPITE FILTER USAGE. IT IS NOT KNOWN IF THROMBI PASSED THROUGH THE FILTER, OR ORIGINATED FROM SUPERIOR OR COLLATERAL VESSELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH KLIPPEL-TRENAUNAY-WEBER SYNDROME, WITH A HISTORY OF PE, AND DVT WAS PLACED ON COUMADIN. SUBSEQUENTLY, AFTER A SYNCOPAL EPISODE, A CT DEMONSTRATED PE IN SPITE OF COUMADIN AND AN INR OF 2. THREE DAYS LATER, THE PHYSICIAN NOTED CLOT IN THE RIGHT GREATER SAPHENOUS VEIN, HUGE PELVIC AND THIGH VARICOSITIES AS WELL AS VESSEL MALFORMATIONS. A VENA CAVA FILTER WAS THEN PLACED. THE PT WAS ALSO PLACED ON LOW MOLECULAR WEIGHT HEPARIN AND WAS DISCHARGED FROM THE HOSPITAL. HE WAS RE-ADMITTED THE NEXT DAY WITH CHEST PAIN AND SHORTNESS OF BREATH. CT SCANS TAKEN 8 DAYS LATER SHOWED EXTENSIVE PE WITHIN BOTH PULMONARY ARTERIES, AND THE FILTER HAD MIGRATED CEPHALAD APPROX 2.1 CM. A CT SCAN TAKEN 7 DAYS LATER SHOWED A TILTED FILTER AND EXTENSIVE BILATERAL PULMONARY EMBOLI. IT WAS REPORTED THAT THIS MAY HAVE REPRESENTED RECURRENT AND/OR RESIDUAL PE FROM A PREVIOUS EPISODE. IT WAS REPORTED THAT THE PT "CODED" FOUR MINS AFTER THE COMPLETION OF THIS CT. RESUSCITATION WAS NOT SUCCESSFUL. REPORTED CAUSE OF DEATH WAS PE. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM-FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFRL1992

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death