BEUDAMED
    FDA Adverse Event Death Summary report: N

    G2 X FILTER SYSTEM - FEMORAL

    MDR report key: 1653469 · Received March 29, 2010

    Report

    Report Number
    2020394-2010-00107
    Event Type
    Death
    Date Received
    March 29, 2010
    Report Date
    March 2, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K082305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND IN THE RECORDS TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER. THE FILTER REMAINS IMPLANTED; THEREFORE, NOT AVAILABLE FOR EVALUATION. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYSTEMIC VASCULAR COAGULATION SYMPTOMS INVOLVING THROMBOSIS IN BOTH THE VENOUS AND ARTERIAL SYSTEM. APPROXIMATELY SIX HOURS POST SUCCESSFUL FILTER IMPLANT FOR DVT EXTENDING FROM THE RIGHT POPLITEAL VEIN TO THE ILIAC VEIN, THE PATIENT RETURNED TO THE ER IN A HYPOTENSIVE STATE, COMPLAINING OF LEFT LEG PAIN. IMAGING IDENTIFIED EXTENSIVE BILATERAL THROMBUS EXTENDING FROM BOTH POPLITEAL VEINS INTO THE VENA CAVA, WITH THROMBUS NOTED WITHIN THE FILTER AND ABOVE THE FILTER. REPORTEDLY, THE FILTER WAS LOCATED AND PROPERLY POSITIONED BELOW THE LOWEST RENAL VEIN. REPORTEDLY, AN AORTIC BYPASS WAS PERFORMED AND VENOUS THROMBOLYSIS WERE PERFORMED. THE PATIENT EXPIRED AFTER THE AORTIC BYPASS PROCEDURE. AN AUTOPSY WILL NOT BE PERFORMED. THE PATIENT'S CAUSE OF DEATH IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 X FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFTH3225

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death STEROIDS