BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1060414 · Received June 12, 2008

    Report

    Report Number
    2953161-2008-00146
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 11, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.

    Description of Event or Problem · 1

    AS REPORTED, IN 2007, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES. AT AN UNKNOWN DATE AN UNSPECIFIED ENDOLEAK WAS OBSERVED. IN 2008, A REVIEW OF THE FILMS BY GORE DEMONSTRATED SAC GROWTH IN THE ABSENCE OF ENDOLEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES, INC. WLG325 05234282

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other