BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1900908 · Received November 10, 2010

    Report

    Report Number
    1820334-2010-00589
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DELIVERY SYSTEM SEPARATION IS NOT SPECIFICALLY LABELED IN THE IFU. THE DEVELOPMENT OF ALL ZENITH DEVICES SUCCESSFULLY COMPLETED ALL VERIFICATION AND VALIDATION ACTIVITIES SHOWING THE DEVICE MET THE DESIGN REQUIREMENTS AND THAT THE REQUIREMENTS MET THE NEEDS OF THE USER. (B)(4) LOADING QUALITY CONTROL REQUIRES CONFIRMATION OF THE TRIGGER WIRE SECURITY WITH THE TRIGGER GRIP. THE TRIGGER GRIPS USED ON THIS DEVICE WERE BUILT PRIOR TO A VENDOR'S CHANGE WHICH ADDRESSED THIS ISSUE. THE VENDOR IMPLEMENTED A CHANGE ON (B)(4), REDUCING THE LIKELIHOOD THAT THIS FAILURE MODE WILL OCCUR IN THE FUTURE. THE FAILURE MODE ASSIGNED TO THIS CASE IS SEPARATED. THIS FAILURE MADE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. IF ADD'L INFO REGARDING THE EVENT OR THE DEVICE USED BECOMES AVAILABLE IN THE FUTURE, THIS REPORT SHALL BE AMENDED AT THE APPROPRIATE TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    PROXIMAL TOP CAP RELEASE WIRE WAS NOT ATTACHED TO THE PUCK, IT WAS LYING LOOSE. WHEN PHYSICIAN UNDID THE FIRST PUCK, IT CAME OFF WITH NOTHING ATTACHED TO IT, SO THEY HAD TO USE FORCEPS TO RETRIEVE THE TOP CAP RELEASE WIRE. THERE WAS ALSO BLOOD LEAKING THROUGH THE CHANNEL OF THE WIRES. PT'S 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 2322582

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK