BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE-TEX VASCULAR GRAFT

    MDR report key: 1140073 · Received August 29, 2008

    Report

    Report Number
    2017233-2008-00534
    Event Type
    Death
    Date Received
    August 29, 2008
    Date of Event
    June 30, 2008
    Report Date
    August 27, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED, IN 2008, THIS PT PRESENTED WITH A RUPTURED THORACOABDOMINAL AORTIC ANEURYSM. A BYPASS WAS PERFORMED USING A HEMASHIELD BIFURCATED AND 8MM GORE-TEX VASCULAR GRAFT. TWO GORE TAG THORACIC ENDOPROSTHESIS WERE THEN IMPLANTED, INTENTIONALLY COVERING THE RENAL, SUPERIOR MESENTERIC, AND CELIAC ARTERIES. THE NEXT DAY, AND THE FOLLOWING DAY AFTER, OPEN ABDOMINAL SURGERY WAS PERFORMED. THE PT EXPIRED IN 2008, FROM BOWEL ISCHEMIA. FURTHER INVESTIGATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX VASCULAR GRAFT NONE MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death