BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2893440 · Received September 29, 2008

    Report

    Report Number
    2017233-2008-00016
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    August 30, 2008
    Report Date
    September 29, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PT PRESENTED WITH ABDOMINAL AND BACK PAIN. A GORE EXCLUDER AAA ENDOPROSTHESIS WAS EXPLANTED DURING AN OPEN CONVERSION. THE PT TOLERATED THE PROCEDURE. 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 WLG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention