BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2861796 · Received November 7, 2012

    Report

    Report Number
    1820334-2012-00513
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - VALVE LEAKS ARE NOT SPECIFICALLY ADDRESSED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT EVAR ON (B)(6) 2012. AFTER REMOVING THE POSITIONER FROM THE SHEATH, THE PHYSICIAN TRIED CLOSING THE HEMOSTATIC VALVE. THE PHYSICIAN QUESTIONED IF IT WAS BEING CLOSED CORRECTLY BECAUSE OF THE AMOUNT OF LEAKAGE. A DILATOR WAS THEN PLACED INTO THE VALVE TO ATTEMPT TO STOP THE BLEEDING, BUT WAS UNSUCCESSFUL. THE PHYSICIAN IS UNSURE AS TO WHAT THE EXACT PROBLEM IS WITH THE VALVE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL RPTR, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    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 3245838

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR