BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROTHESIS

    MDR report key: 1080509 · Received July 22, 2008

    Report

    Report Number
    2953161-2008-00183
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 22, 2008
    Report Date
    July 21, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.

    Description of Event or Problem · 1

    AS REPORTED, IN 2008, THIS PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS ILIAC EXTENDER COMPONENT AND A BARE METAL STENT (MANUFACTURER UNK) TO REPAIR A LEFT COMMON ILIAC ARTERY ANEURYSM. ON ELEVEN DAYS LATER, A DISSECTION ORIGINATING FROM THE LEFT COMMON ILIAC ARTERY TO THE LEVEL OF THE RENAL ARTERIES WAS OBSERVED. THE PT WAS GIVEN HYPERTENSION MEDICATION AND WILL CONTINUE TO BE MONITORED BY THE PHYSICIAN. ACCORDING TO THE PHYSICIAN, THE DISSECTION MAY HAVE BEEN CAUSED BY THE GUIDEWIRES (MANUFACTURER UNK) USED DURING THE ENDOVASCULAR REPAIR. ON TWO DAYS LATER, THE PT UNDERWENT A REINTERVENTION IN WHICH A COOK ZENITH AAA ENDOVASCULAR GRAFT WAS IMPLANTED. THE PT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROTHESIS NONE MIH W. L. GORE & ASSOCIATES, INC. WLG325 05556828

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other