BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1821260 · Received August 26, 2010

    Report

    Report Number
    2017233-2010-00380
    Event Type
    Death
    Date Received
    August 26, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 26, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS HAS NOT BEEN EVALUATED IN PATIENT POPULATIONS INCLUDING RUPTURED ANEURYSMS. ADDITIONAL DEVICES IMPLANTED: PXC121200/7688886, PXC201000/7779249, PXC121200/06777605, PXA260300/06203244.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURE OF A PREVIOUSLY UNDIAGNOSED INFRARENAL ABDOMINAL AORTIC ANEURYSM. THE RUPTURE WAS TREATED ENDOVASCULARLY WITH GORE EXCLUDER ENDOPROSTHESES. THREE HOURS POST OPERATIVELY, THE PATIENT WAS RETURNED TO THE OPERATING ROOM WITH COMPARTMENT SYNDROME. PATENT LUMBAR ARTERIES WERE FOUND TO BE COMMUNICATING WITH THE RUPTURED ANEURYSM SAC. THE PHYSICIAN EXPLANTED THE TRUNK-IPSILATERAL LEG COMPONENT AND WAS IN THE PROCESS OF SEWING IN A VASCULAR GRAFT WHEN THE PATIENT 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 7188502

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death PATIENT WAS ON BENICAR FOR HIGH BLOOD PRESSURE.