BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1935374 · Received December 21, 2010

    Report

    Report Number
    1820334-2010-00651
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 16, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE: ENDOLEAK IS ADDRESSED IN THE IFU. EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT INITIAL ENDOVASCULAR ABDOMINAL AORTIC REPAIR ON (B)(6) 2010. ON F/U CT SCAN DATED (B)(6) 2010, THERE IS A PROXIMAL TYPE I ENDOLEAK AND THE GRAFT APPEARS TO COVER THE RT RENAL ARTERY WHICH IT DID NOT AT THE TIME OF IMPLANT. FILMS ARE BEING REVIEWED FOR RECOMMENDATION OF SECONDARY INTERVENTION. SECONDARY PROCEDURES TO BE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2470931

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other