BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3001347 · Received March 6, 2013

    Report

    Report Number
    2017233-2013-00112
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    December 10, 2012
    Report Date
    February 7, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2012, THIS PT PRESENTED WITH A SPONTANEOUS PSOAS HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95226 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7679258

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other (B)(4)