BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROTHESIS

    MDR report key: 2893409 · Received December 21, 2012

    Report

    Report Number
    2017233-2012-00863
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    May 17, 2012
    Report Date
    November 28, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: PXC141400/06147268 AND PXL161407/05881735. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THIS PT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2012, THE PT UNDERWENT A REOPERATION; TWO ADDITIONAL GORE EXCLUDER AAA ENDOPROSTHESES WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06537119

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention