BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2161724 · Received July 8, 2011

    Report

    Report Number
    2017233-2011-00333
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 8, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT WAS BEING TREATED FOR AN EMERGENT RUPTURED ABDOMINAL AORTIC ANEURYSM USING A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3. DURING THE PROCEDURE, IT WAS REPORTED THAT AFTER THE INITIAL DEPLOYMENT OF THE PROXIMAL END OF THE GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 WAS RELEASED THE DEVICE MOVED DISTALLY APPROXIMATELY 2.5CM. THE DEVICE WAS RECONSTRAINED AND PUSHED BACK UP TO THE DESIRED LOCATION. AN ANGIOGRAM CONFIRMED THAT THE DEVICE MOVED DISTALLY AGAIN APPROXIMATELY 1CM. THE PHYSICIAN CHOSE TO LEAVE THE DEVICE AT THE CURRENT LOCATION. WHEN IT CAME TIME TO FULLY DEPLOY THE DEVICE, THE PROXIMAL PORTION OF THE DEVICE WOULD NOT FULLY EXPAND. A COTA BALLOON WAS INSERTED INTO THE PATIENT AND FULLY INFLATED THREE TIMES TO OPEN UP THE PROXIMAL PORTION OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE PROCEDURE ENDED WITH ADEQUATE SEAL AND NO ENDOLEAKS WERE REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

    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 WLG425 8486869

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R