BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1541452 · Received November 17, 2009

    Report

    Report Number
    2017233-2009-90028
    Event Type
    Death
    Date Received
    November 17, 2009
    Date of Event
    May 14, 2008
    Report Date
    November 17, 2009
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE GORE EXCLUDER AAA ENDOPROSTHESIS IS INTENDED FOR A MINIMUM AORTIC NECK LENGTH OF 15MM. ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ANEURYSM RUPTURE, SURGICAL CONVERSION AND DEATH. ADDITIONAL DEVICES IMPLANTED.

    Description of Event or Problem · 1

    IN 2008, THE PT WAS IMPLANTED WITH 7 GORE EXCLUDER AAA ENDOPROSTHESES TO REPAIR AN ENLARGING, 6CM ABDOMINAL AORTIC ANEURYSM. POST-IMPLANT COMPLICATIONS INCLUDED CARDIAC ARREST, BLEEDING, RETROPERITONEAL HEMATOMA, BRADYCARDIA, RESPIRATORY ARREST WITH RESUSCITATION, RUPTURE OF ABDOMINAL ANEURYSM WITH OPEN SURGICAL REPAIR, BYPASS GRAFTING AND THREE OPEN ABDOMINAL EXPLORATORY SURGERIES. THE PT CONTINUED TO DECLINE AND REMAINED HYPOTENSIVE DESPITE MULTIPLE BLOOD TRANSFUSIONS. TWO DAYS LATER, AFTER PROGRESSIVE DETERIORATION, THE PT'S FAMILY REQUESTED COMFORT CARE ONLY AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG325 05528850

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| H| O| R