BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1931576 · Received December 13, 2010

    Report

    Report Number
    2953161-2010-00226
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    April 9, 2009
    Report Date
    December 13, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED. PLEASE NOTE ADDITIONAL DEVICES INVOLVED: PXA230300/03890479, PXA230300/06264014, PXA230300/06212756, PXA230300/06212755, PXA230300/05774867, PXA260300/05153365.

    Description of Event or Problem · 1

    ON (B)(6), 2005, THIS PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN INFRARENAL SACCULAR AORTIC ANEURYSM. ON (B)(6), 2009, THE PATIENT WAS IMPLANTED WITH AORTIC EXTENDER COMPONENTS TO ADDRESS INFRARENAL AORTIC PSEUDOANEURYSMS. ON (B)(6), 2009, THE PATIENT WAS IMPLANTED WITH AN AORTIC EXTENDER COMPONENT TO ADDRESS A PROXIMAL TYPE I ENDOLEAK WITH PSEUDOANEURYSM FORMATION. ON (B)(6), 2009, THIS PATIENT PASSED AWAY. CAUSE OF DEATH WAS SEPTIC SHOCK.

    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, INC. WLG425 03810392

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H| R