BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2234082 · Received August 29, 2011

    Report

    Report Number
    2017233-2011-00441
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    February 2, 2011
    Report Date
    August 25, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO REGARDING THIS EVENT HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE PT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH THE GORE EXCLUDER AAA ENDOPROSTHESIS. DURING THE IMPLANTATION OF THE CONTRALATERAL LEG COMPONENT THE PT ILIAC ARTERY RUPTURED AND THE PHYSICIAN CONVERTED THE PT TO OPEN SURGICAL REPAIR. THE PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention