BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH

    MDR report key: 922454 · Received August 9, 2007

    Report

    Report Number
    922454
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    August 2, 2007
    Report Date
    August 9, 2007
    Manufacturer
    COOK CRITICAL CARE, INC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT STATUS POST REPAIR OF AN INFRARENAL DIRECT ANEURYSM PLACED SIX YEARS AGO USING AN ANEURX STENT GRAFT (26MM-15MM-165MM) THAT MIGRATED CAUDALLY FROM INITIAL DEPLOYMENT SITE CAUSING UNSTABLE, UNSAFE CONDITION.AFTER THE COOK RENU MAIN BODY EXTENSION RX1-26-43 (LOT 1000478) WAS PREPARED PER INSTRUCTIONS, IT WAS INTRODUCED ON THE RIGHT SIDE. AFTER CONFIRMATION THAT THE FOUR GOLD RADIOPAQUE MARKERS WERE 2 MM INFERIOR TO THE LEFT RENAL ARTERY, IT WAS DEPLOYED INTO THE INFRARENAL NECK OF THE AORTA EXTENDING INTO THE PROXIMAL TRUNK OF THE ANEURX STENT GRAFT BY WITHDRAWAL OF SHEATH WHILE STABILIZING THE GREY POSITIONER. AS DESIRED, ONE STENT BODY WAS WITHIN THE TRUNK AND ONE ABOVE. AFTER ANGIOGRAPHIC CONFIRMATION OF APPROPRIATE POSITIONING, THE BLACK TRIGGER WIRE WAS RELEASED AND THE BARE SUPRARENAL STENT WITH FIXATION BARBS WAS DEPLOYED. THE WHITE TRIGGER WIRE WAS THEN RELEASED. AFTER LOOSENING OF THE PIN VISE AND SECURING THE INNER CANNULA, THE GREY POSITIONER WAS ADVANCED UNDER ULTRASONIC GUIDANCE TO DOCK WITH THE TOP CAP. SOME RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE GREY POSITIONER. AFTERWARDS, THE ENTIRE COOK RENU MAIN BODY EXTENSION WAS OBSERVED TO RAPIDLY "JUMP" CEPHALAD APPROXIMATELY TWO VERTEBRAL LEVELS INTO THE LOWER THORACIC AORTA WITH THE DISTAL END OF THE CONVERTER AT THE LOWER T12 LEVEL. AN AORTOGRAM SHOWED PARTIAL COVERAGE OF THE CELIAC ARTERY ORIGIN BY THE LOWER ASPECT OF THE GRAFT WITH SLOW FLOW IN THIS VESSEL. THE COOK RENU MAIN BODY EXTENSION WAS SLOWLY ADVANCED WITHOUT RESISTANCE UNTIL ITS LOWER MARGIN WAS AT THE UPPER T12 LEVEL TO RESTORE FULL FLOW IN THIS VESSEL AS WELL AS TO AVOID COVERING OF THE ARTERY OF ADAMKIEWICZ, WHICH WAS IDENTIFIED ON THE PREVIOUS COMPUTED ANGIOGRAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH STENT GRAFT, VASCULAR MIH COOK CRITICAL CARE, INC. * 1845076

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR NO OTHER THERAPIES