BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2061403 · Received March 18, 2011

    Report

    Report Number
    1820334-2011-00128
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): LEAKS OF THE DELIVERY SYSTEM ARE NOT SPECIFICALLY LABELED. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS PLACED ACCORDING TO THE IFU. DURING THE PROCEDURE THERE WAS A CONSTANT DRIPPING OF BLOOD LEAKING OUT OF THE CAPTOR VALUE ON THE SHEATH. THE LEAK WAS COMING FROM BETWEEN THE BLUE CAPTOR VALUE AND THE WHITE BAND WITH DEVICE LABEL. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    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 2571907

    Patients

    Seq Age Sex Outcome Treatment
    1