BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 474643 · Received July 22, 2003

    Report

    Report Number
    2953161-2003-00014
    Event Type
    Death
    Date Received
    July 22, 2003
    Date of Event
    June 25, 2003
    Report Date
    July 21, 2003
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT IS BELIEVED THAT THE LEFT COMMON ILIAC WAS PERFORATED DURING PREPARATION FOR DELIVERY OF THE EXCLUDER BIFURCATED ENDOPROSTHESIS BY ONE OF THE VASCULAR ACCESS ACCESSORY DEVICES UTILIZED BY THE SURGICAL TEAM. THE PERFORATION WAS NOT INITIALLY DETECTED, AND THE PROCEDURE PROGRESSED AS PLANNED. THE ENDOPROSTHESIS WAS PLACED AND DEPLOYED SUCCESSFULLY. UPON FINAL ANGIOGRAM, EXTRAVASATION WAS NOTED ON THE LEFT COMMON PROXIMAL TO THE INTERNAL/EXTERNAL BIFURCATION. THE PT'S PRESSURE WAS BROUGHT TO THE SURGEON'S ATTENTION. THE PT WAS STABILIZED AND AN ADD'L CONTRALATERAL LIMB WAS PLACED TO EXTEND TO THE L2 BIFURCATION. A RETROGRADE INJECTION OF CONTRAST REVEALED A PERSISTENT LEAK, THEREFORE AN ILIAC EXTENDER WAS PLACED INTO THE LEFT EXTERNAL ILIAC. THE NEXT RETROGRADE INJECTION INDICATED THAT NO LEAK WAS PRESENT. THE PT WAS STABLE AND MOVED TO RECOVERY. APPROXIMATELY TWO HOURS LATER, THE SURGEON WAS NOTIFIED THAT THE PT WAS EXPERIENCING DIFFICULTY AND SHORTLY THEREAFTER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLUDER BIFURCATED ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES, INC. WLG325 0212716

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death