BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2798654 · Received October 15, 2012

    Report

    Report Number
    2017233-2012-00712
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    January 1, 2010
    Report Date
    September 16, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - LOT NUMBERS, PATIENT INFORMATION, EVENTS, AND IMAGES WERE NOT AVAILABLE, THEREFORE NO EVALUATION COULD BE CONDUCTED. RESULTS - AS LOT NUMBERS AND IMAGES WERE NOT AVAILABLE, THEREFORE NO EVALUATION COULD BE CONDUCTED.

    Description of Event or Problem · 1

    GORE WAS MADE AWARE OF INFORMATION FROM A PUBLISHED LITERATURE ARTICLE, LIND B, JACOBS C. PRIMARY AORTODUODENAL FISTULA SUPPLIED BY TYPE II ENDOLEAK. ANNALS VASCULAR SURGERY 2012; 26(7): 1012.E13-1012.E15. THE ARTICLE REPORTS A (B)(6) MAN WITH MULTIPLE COMORBIDITIES PRESENTED TO THE INSTITUTION FOR EVALUATION OF GASTROINTESTINAL (GI) BLEEDING AND POSSIBLE MYOCARDIAL INFARCTION. IN 2007, THIS PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IN 2008 A TYPE I ENDOLEAK WAS DETECTED AND REPAIRED WITH PROXIMAL CUFF PLACEMENT. ON AN UNKNOWN DATE, AN AXILLARY-BIFEMORAL BYPASS GRAFTING ORIGINATED FROM THE LEFT AXILLARY ARTERY WAS PERFORMED. AFTERWARD,THE SURGICAL TEAM EXPOSED THE SUPRACELIAC AORTA AND THE ANEURYSM WAS DISSECTED. BOTH COMMON ILIAC ARTERIES WERE EXPOSED. THE DUODENUM WAS DISSECTED OFF OF THE ANEURYSM, AND A FISTULA FROM THE DUODENUM TO THE SAC WAS IDENTIFIED. THERE WAS NO PORTION OF GRAFT PROTRUDING FROM THE ANEURYSM, AND A FISTULA FROM THE DUODENUM TO THE SAC WAS IDENTIFIED. THERE WAS NO PORTION OF GRAFT PROTRUDING FROM THE AORTA. THE ANEURYSM SAC WAS THEN OPENED, AND THE DEVICE WAS REMOVED WITH FIRM TRACTION. THE PATENT LUMBAR ARTERY WAS IDENTIFIED AND OVERSEWN. THE INFRARENAL AORTA WAS OVERSEWN IN MULTIPLE LAYERS, AS WAS THE DISTAL AORTA PROXIMAL TO THE BIFURCATION. A DECOMPRESSIVE GASTROTOMY TUBE AND A JEJUNOSTOMY TUBE WERE PLACED. THE BYPASSES WERE FOUND TO BE THROMBOSED, AND THROMBECTOMY THROUGH THE GROINS WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. HOWEVER, HIS POSTOPERATIVE COURSE WAS COMPLETED BY UPPER GI BLEEDING FROM GASTRIC ULCERS, HE ALSO DEVELOPED AN INFECTION IN HIS RIGHT GROIN. THE PATIENT EXPIRED THREE MONTHS AFTER PRESENTATION FROM COMPLICATIONS OF PERSISTENTLY BLEEDING GASTRIC ULCERS.

    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,INC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R