BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1081493 · Received July 23, 2008

    Report

    Report Number
    2017233-2008-00397
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 22, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED, IN 2004, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES. ON AN UNK DATE, THE PT PRESENTED WITH ANEURYSM ENLARGEMENT AND A POSSIBLE TYPE III ENDOLEAK. FURTHER INVESTIGATION IS BEING CONDUCTED. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other