BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1841099 · Received September 16, 2010

    Report

    Report Number
    2017233-2010-00404
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    January 16, 2009
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. FURTHER INVESTIGATION IS BEING CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN UNK CAUSE. ON (B)(6) 2009, THE DEVICES WERE EXPLANTED. FURTHER INVESTIGATION IS BEING CONDUCTED.

    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 04934819

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R