BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1832002 · Received September 8, 2010

    Report

    Report Number
    2953161-2010-00163
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 7, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT UNDERWENT REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. THE TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED WITH NO PROBLEMS. THE PHYSICIAN THEN TRIED TO CANNULATE THE GATE; HOWEVER, AFTER MULTIPLE ATTEMPTS WAS UNABLE TO DO SO. AN UNPLANNED AORTO-UNI-ILIAC AND A FEMORAL-FEMORAL BYPASS WERE PERFORMED. THE PT TOLERATED THE PROCEDURE.

    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 7796919

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R