BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3021057 · Received March 13, 2013

    Report

    Report Number
    2953161-2013-00041
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    June 6, 2012
    Report Date
    February 20, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE ADDITIONAL PROCEDURE COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION. ADDITIONAL DEVICE IMPLANTED AND INVOLVED IN THIS EVENT: RMT261414/8121616. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2012 AN ADDITIONAL ILIAC EXTENDER COMPONENT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106445 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 8682602

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R