BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 3023292 · Received February 28, 2013

    Report

    Report Number
    1820334-2013-00108
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLOOD LOSS IS LABELED IN THE IFU. VALVE LEAKS ARE NOT SPECIFICALLY LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT EVAR ON (B)(6) 2013. WHEN THE GREY INTRODUCER WAS REMOVED FROM THE CAPTOR HEMOSTATIC VALVE ON THE FLEX MAIN BODY SHEATH, THERE WAS EXCESSIVE BLEEDING FROM THE SHEATH DESPITE CLOSING THE VALVE TO THE CLOSED POSITION. ESTIMATED BLOOD LOSS WAS AROUND 1000ML'S. THE GRAFT WAS SUCCESSFULLY DEPLOYED. AT THIS TIME, IT IS BELIEVED THAT THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE AND NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAS NOT BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88477 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH COOK, INC. NA 2881195

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR