BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2338059 · Received November 7, 2011

    Report

    Report Number
    2017233-2011-00587
    Event Type
    Injury
    Date Received
    November 7, 2011
    Date of Event
    October 17, 2011
    Report Date
    November 4, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS REVIEW VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICE IMPLANTED/EXPLANTED: PXC121000/9180601.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT WAS UNDERGOING REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. THE GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 WAS DEPLOYED WHERE INTENDED. UPON BALLOONING WITH A MEDTRONIC RELIANT BALLOON, EXTRAVASATION WAS NOTED FROM THE AORTA. THE PATIENT WAS CONVERTED TO OPEN REPAIR, THE DEVICES WERE EXPLANTED AND DISCARDED. 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 8861780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R