BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2170681 · Received July 12, 2011

    Report

    Report Number
    2017233-2011-00339
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    January 1, 2010
    Report Date
    July 12, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6), 2006, THE PATIENT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. A TYPE II ENDOLEAK WAS NOTED AT THE TIME OF THE ORIGINAL PROCEDURE SO COILS WERE PLACED WITHIN THE ANEURYSM SAC. THE ENDOLEAK APPEARED TO BE RESOLVED. ON (B)(6), 2009, A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED THE ANEURYSM MEASURED 5.2CM X 5.1CM. IN (B)(6) 2010 (EXACT DATE UNKNOWN), A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED THE ANEURYSM MEASURED 6.2CM. ON (B)(6), 2011, A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED THE ANEURYSM MEASURED 6.9CM. ON (B)(6), 2011, A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED A PERSISTENT TYPE II ENDOLEAK WITH RETRO GRADE FLOW FROM BILATERAL ILIO-LUMBAR ARTERIES AND A POSSIBLE PROXIMAL TYPE I ENDOLEAK WAS ALSO NOTED. THE PATIENT IS DOING WELL AND THE DEVICES REMAIN INSIDE THE PATIENT AT THIS TIME.

    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 03772339

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other (B)(4)| (B)(4)