BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2234085 · Received August 29, 2011

    Report

    Report Number
    2017233-2011-00445
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 29, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK IS BEING CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PT REPORTEDLY UNDERWENT TREATMENT FOR A SYMPTOMATIC QUESTIONABLE CONTAINED RUPTURED ABDOMINAL AORTIC RUPTURE WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED THE PROCEDURE WENT WITHOUT INCIDENT, THERE WAS NO EVIDENCE OF ENDOLEAK ON POST-IMPLANT IMAGING, AND THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2011, THE PT REPORTEDLY PRESENTED WITH ABDOMINAL PAIN, AND COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DEMONSTRATED AN UNSPECIFIED ENDOLEAK AND CONTAINED RUPTURE. THE PT WAS REPORTEDLY TAKEN TO THE OPERATING ROOM FOR OPEN ANEURYSM REPAIR AND EXPLANT OF THE GORE EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE DEVICES WERE WELL OPPOSED IN THE PT'S AORTA. THE PT TOLERATED THE PROCEDURE. ADDITIONAL INFO HAS BEEN REQUESTED.

    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 WLG425 9094402

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R (B)(4)/8917090