BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1020377 · Received March 28, 2008

    Report

    Report Number
    2953161-2008-00066
    Event Type
    Death
    Date Received
    March 28, 2008
    Date of Event
    January 3, 2008
    Report Date
    March 28, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OCCLUSION.

    Description of Event or Problem · 1

    IN (B)(6) 2008, A GORE EXCLUDER AAA ENDOPROSTHESIS WAS IMPLANTED. ONE TO TWO DAYS POSTOPERATIVELY, A DEVICE LIMB OCCLUDED. A FEMOROFEMORAL BYPASS GRAFT WAS IMPLANTED. HOWEVER, DURING THE PROCEDURE THE PT HAD A HEART ATTACK. IT WAS REPORTED THAT THE FEMOROFEMORAL BYPASS GRAFT OCCLUDED AND TWO DAYS LATER THE PT DIED. THE CAUSE OF DEATH WAS A HEART ATTACK. ACCORDING TO THE PHYSICIAN, THE PT'S DEATH WAS RELATED TO A PRE-EXISTING MEDICAL CONDITION.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death