BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1063437 · Received June 19, 2008

    Report

    Report Number
    2953161-2008-00156
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK IS BEING CONDUCTED.

    Description of Event or Problem · 1

    GORE'S HISTOLOGY SERVICES RECEIVED EXPLANTED GORE EXCLUDER AAA ENDOPROSTHESES IN 2008. THE PT WAS ORIGINALLY IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES IN 2004. THE DEVICES WERE EXPLANTED IN 2008. FURTHER INVESTIGATION IS BEING CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 042990211

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention