BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2062666 · Received April 11, 2011

    Report

    Report Number
    2953161-2011-00087
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    July 6, 2010
    Report Date
    April 8, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: AS STATED IN THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, COMPLICATIONS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMIT TO, ENDOLEAK. ADDITIONAL GORE DEVICE RELATED TO THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2010, THE PT WAS IMPLANTED WITH AN ADDITIONAL GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT A DISTAL TYPE-1 ENDOLEAK AND AN ILIAC ARTERY ANEURYSM. THE PT TOLERATED THE PROCEDURE WELL.

    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 WLG425 7397121

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R LIPITOR| PRILOSEC| LEXAPRO| CARDURA| COREG