BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1191443 · Received September 25, 2008

    Report

    Report Number
    1820334-2008-00545
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE ANATOMICAL REQUIREMENTS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THE IFU ALSO RECOMMENDS USING A COOK LUNDERQUIST EXTRA STIFF WIRE GUIDE. USE OF THIS SPECIFIC WIRE GUIDE COULD PREVENT AND/OR REDUCE THE PROBABILITY OF THIS FAILURE FROM OCCURRING. THE DEVICE REMAINS IMPLANTED. THE DELIVERY SYSTEM AND IMAGES HAVE NOT BEEN PROVIDED TO ASSIST IN THIS INVESTIGATION. WITHOUT THE DELIVERY SYSTEM OR IMAGES WERE ARE UNABLE TO DETERMINE WITH CERTAINTY WHY DIFFICULTY WAS ENCOUNTERED, BUT AN INTERNAL CLINICAL REVIEW DID INDICATE THIS MAY BE DUE TO PRODUCT QUALITY. WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A MALE UNDERWENT AAA REPAIR IN 2008. THE MAIN BODY GRAFT WAS DEPLOYED IN SEQUENCE. THE CONTRALATERAL LEG WAS PLACED. THEN, WHILE DEPLOYING THE FINAL TWO STENTS ON THE IPSILATERAL SIDE OF THE MAIN BODY AND THE PHYSICIAN RELEASED THE TRIGGER WIRE. THE PIN VISE WAS LOOSENED. THE PHYSICIAN COULD NOT MOVE THE GREY POSITIONER THROUGH THE IPSILATERAL LIMB TO DOCK THE TOP CAP. EACH TIME THEY MET RESISTANCE. THEY THEN TRIED TO PULL THE TOP CAP THROUGH WITHOUT DOCKING BUT WERE UNSUCCESSFUL. FINALLY A LIMA GUIDE CATHETER WAS ADVANCED UP THE CONTRALATERAL SIDE ON A JWIRE. THE SUPER STIFF AMPLATZ WAS ALONG SIDE AS A "BUDDY WIRE". THE SURGEON CANNULATED THE TOP CAP WITH THE LIMA CATHETER. WHILE PUSHING UP AND AWAY FROM THE AREA OF RESISTANCE WITH THE LIMA, THE TOP CAP WAS PULLED DOWN THROUGH THE GARFT WITHOUT DOCKING INTO THE GREY POSITIONER UNTIL THE COMMON ILIAC. THE WIRE USED WHEN THE LIMA WAS USED WAS A JWIRE. A STIFF WIRE WAS LEFT UP THERE THE WHOLE TIME. PATIENT IS FINE.

    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 2102680

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR