BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3131407 · Received May 7, 2013

    Report

    Report Number
    2953161-2013-00061
    Event Type
    Injury
    Date Received
    May 7, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: PXC161000/10735865. THE REVIEW OF THE MANUFACTURING AND STERILIZATION PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THIS PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED ON (B)(6) 2013, THE PHYSICIAN EXPLANTED ALL THE GORE DEVICES DUE TO A PHLEGMON. THE VASCULATURE WAS REPAIRED SURGICALLY WITH AN AORTIC HOMOGRAFT FROM CRYOLIFE INC. AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200142 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 10536761

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention