BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1882369 · Received October 22, 2010

    Report

    Report Number
    2953161-2010-00195
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    October 21, 2008
    Report Date
    October 22, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, TYPE II ENDOLEAKS ARE A KNOWN RISK FACTOR FOR ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. PLEASE NOTE ADDITIONAL DEVICES IMPLANTED: (B)(4) AND (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2006, A SMALL TYPE II ENDOLEAK WAS NOTED WITH NO ANEURYSM GROWTH. ON (B)(6) 2007, THE ENDOLEAK PERSISTED WITH NO ANEURYSM GROWTH. ON (B)(6) 2007, THE TYPE II ENDOLEAK PERSISTED WITH NO ANEURYSM GROWTH. ON (B)(6) 2008, THE TYPE II ENDOLEAK PERSISTED AND THE ANEURYSM GREW IN SIZE FROM 5.6 CM TO 6.3 CM. ON (B)(6) 2009, THE TYPE II ENDOLEAK PERSISTED AND THE ANEURYSM GREW TO 6.6 CM. ON (B)(6) 2009, THE TYPE II ENDOLEAK PERSISTED AND THE ANEURYSM SAC GREW TO 7.2 CM. IN (B)(6) 2009, THE PATIENT'S CARE WAS TRANSFERRED TO ANOTHER PHYSICIAN.

    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, INC. WLG325 042230108

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR