BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1914932 · Received November 29, 2010

    Report

    Report Number
    2953161-2010-00219
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    September 26, 2006
    Report Date
    November 29, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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), 2005, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2006, AN ADD'L PROCEDURE WAS PERFORMED TO TREAT A PROXIMAL TYPE I ENDOLEAK. FOUR ADD'L GORE EXCLUDER AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENTS WERE IMPLANTED TO SUCCESSFULLY TREAT THE ENDOLEAK. 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 03941527

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R