BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2112268 · Received May 24, 2011

    Report

    Report Number
    2953161-2011-00121
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 24, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THIS PT WAS IMPLANTED WITH GORE EXCLUDER ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2011, THIS PT WAS IMPLANTED WITH AN AORTIC EXTENDER COMPONENT AND A PALMAZ STENT TO TREAT A PROXIMAL TYPE I ENDOLEAK. THE ENDOLEAK RESOLVED AND THE PT TOLERATED THE PROCEDURE.

    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 06808038

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R KCL| PREDNISONE| COREG| WARFARIN| LISINOPRIL| ASPIRIN| ALPRAZOLAM| GEMFIBROZIL