BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1853466 · Received September 28, 2010

    Report

    Report Number
    2017233-2010-00429
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 27, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS BEING TREATED FOR AN AORTIC ABDOMINAL ANEURYSM WITH TWO GORE EXCLUDER AAA ENDOPROSTHESIS. AFTER DEPLOYMENT OF THE GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT, THE DEPLOYMENT CATHETER WAS REMOVED. THE TORQUE BUMP CAME OUT OF THE SHEATH WITH THE LEADING END BEFORE THE OLIVE. IT CAME OUT OF THE SHEATH SEPARATED FROM THE CATHETER. THERE WAS NO ADVERSE EVENT TO THE PT AND THE ANEURYSM WAS EXCLUDED.

    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 7476739

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR