BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1252228 · Received December 4, 2008

    Report

    Report Number
    2953161-2008-00410
    Event Type
    Death
    Date Received
    December 4, 2008
    Date of Event
    November 2, 2008
    Report Date
    December 3, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. THE MANUFACTURING RECORDS REVIEW VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. POSSIBLE DISTAL EMBOLIZATION DUE TO DEVICE CATHETER MANIPULATION. ADDITIONAL DEVICES: PXC141000/06167444 AND PXL161007/06274381. PXC201000/06202732.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. LATER THAT DAY, THE PATIENT HAD IMPAIRED BLOOD FLOW TO THE LEGS AND WAS RETURNED TO THE OPERATING ROOM FOR A VASODILATOR INJECTION. AT ABOUT TWO DAYS LATER, THE PATIENT UNDERWENT AN ENTERECTOMY TO ADDRESS INTESTINAL ISCHEMIA. AT ABOUT, THE PATIENT EXPIRED DUE TO INTESTINAL NECROSIS. ACCORDING TO THE PHYSICIAN, THE ISCHEMIAS MAY HAVE BEEN DUE TO CATHETER INDUCED EMBOLIZATION FROM THE THORACIC AORTA THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 06271179

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death