BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1020378 · Received March 28, 2008

    Report

    Report Number
    2953161-2008-00064
    Event Type
    Death
    Date Received
    March 28, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 28, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. DEATH. PLEASE NOTE: ATTACHED LIST OF ADD'L DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXC121200/LOT#05693669.

    Description of Event or Problem · 1

    IN 2008, A GORE EXCLUDER AAA ENDOPROSTHESIS WAS IMPLANTED TO REPAIR AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PT'S LEFT HYPOGASTRIC ARTERY WAS INTENTIONALLY COVERED. ON THE NEXT DAY, THE PT HAD ABDOMINAL PAIN, RENAL FAILURE, GASTROINTESTINAL BLEEDING, AND A HEMATOCRIT OF 26 %. AN ENDOSCOPY REVEALED BLACK MUCOSA AND ISCHEMIC COLITIS. ON ONE DAY PRIOR TO ORIGINAL DATE, AN EXPLORATORY LAPAROTOMY REVEALED THAT THE PT HAD A LEFT COLONIC INFARCT. A COLONECTOMY AND RESECTION OF THE RECTUM WAS PERFORMED. ON THE FOLLOWING MONTH, THE PT DIED FROM MULTI ORGAN FAILURE. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W. L. GORE & ASSOCIATES, INC. WLG325 05683663

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death