BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1841111 · Received September 17, 2010

    Report

    Report Number
    2017233-2010-00406
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 16, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    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

    METHOD - A REVIEW OF THE MFG PAPERWORK IS BEING CONDUCTED. RESULTS: THE REVIEW OF THE MFG PAPERWORK HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6), 2010, THE PT WAS IMPLANTED WITH A GORE EXCLUDER AAA AORTIC EXTENDER ENDOPROSTHESIS. FURTHER INVESTIGATION IS IN PROCESS.

    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 WLG325 7498173

    Patients

    Seq Age Sex Outcome Treatment
    1