BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1903532 · Received November 19, 2010

    Report

    Report Number
    1820334-2010-00577
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 20, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - BLOOD LOSS IS LABELED IN THE IFU. (B)(4) - VALVE LEAKS ARE NOT SPECIFICALLY ADDRESSED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE DEVICE WAS BEING UTILIZED FOR AN ENDOVASCULAR AAA REPAIR ON A PATIENT. THE VALVE ON THE SHEATH LEAKED CONTINUALLY THROUGH THE PROCEDURE, OVER 120 MLS OF BLOOD LOSS. PATIENT OUTCOME WAS NOT PROVIDED BY REPORTER.

    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 2544525

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other