BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1963328 · Received January 10, 2011

    Report

    Report Number
    1820334-2011-00015
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 13, 2010
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - BLEEDING IS ADDRESSED IN THE IFU. (B)(4) - VALVE LEAKAGE IS NOT ADDRESSED IN THE IFU. CHECK-FLO DISCS CRITICAL DIMENSIONS ARE INSPECTED DURING INCOMING QUALITY CONTROL. PER SPECIFICATION, INSPECTION OF CAPTOR VALVE ASSEMBLY IS PERFORMED 100% UNLESS OTHERWISE SPECIFIED. THE VALVE COLLAR IS VERIFIED TO BE COMPLETELY SNAPPED INTO THE VALVE CHAMBER AND THE ORIENTATION OF THE CHECK-FLO DISCS ARE CONFIRMED. THE DISCS ARE EXAMINED TO VERIFY THAT EACH IS PUNCTURED AND FREE OF TEARS. A 16 FR PIECE OF TUBING IS PLACED THROUGH THE IRIS VALVE TO CONFIRM THAT THE VALVE OPENS AND CLOSES WITHOUT ISSUE. A LEAK TEST IS PERFORMED ON THE CAPTOR VALVE ASSEMBLY. THE ZENITH DEVICE HAS COMPLETED REQUIREMENTS SHOWING THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH DEVICE IS SHIPPED WITH AN IFU DESCRIBING THE APPROPRIATE WARNINGS AND PRECAUTIONS, CONTRAINDICATIONS, AND THE PROPER DEPLOYMENT PROCEDURE. THE SHEATH ASSEMBLY WAS RETURNED IN A USED AND CONTAMINATED CONDITION. THE RETURNED DEVICE WAS LEAK TESTED USING WATER AND A SYRINGE. THE CAPTOR VALVE WAS FUNCTIONING AND WAS RETURNED IN A CLOSED POSITION. THERE WERE TWO TEARS IN THE WEBBING OF THE CHECK-FLO DISCS WITH THE POSITIONER THROUGH THE DISCS. THE DEVICE LEAKED AT THE BACK OF THE VALVE WITH THE POSITIONER THROUGH THE VALVE AND THE IRIS VALVE OPEN AND CLOSED. THE POSITIONER WAS REMOVED AND THE DEVICE WAS LEAK TESTED WITH THE IRIS VALVE CLOSED. A SMALL LEAK WAS DETECTED BETWEEN THE VALVE CONTROL AND VALVE COLLAR AFTER SIGNIFICANT PRESSURE WAS APPLIED TO THE SYSTEM. THE IRIS VALVE WAS THEN OPENED AND NO LEAKAGE WAS DETECTED. IT IS POSSIBLE THAT THE DISCS RECOVERED INTO A POSITION THAT PREVENTED LEAKAGE DURING TESTING. THE CHECK-FLO DISCS WERE EXAMINED. EACH DISC WAS TORN. DAMAGE TO THE CHECK-FLO DISCS LIKELY RESULTED IN LEAKAGE. WE ARE AWARE OF THE POTENTIAL FOR LEAKAGE THROUGH THE VALVE AND THE RISK ASSOCIATED WITH THIS FAILURE MODE. ENGINEERING IS CURRENTLY EVALUATING AREAS FOR IMPROVEMENT. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED PER QUALITY ENGINEERING RISK ASSESSMENT (QE RA) AND RISK REDUCTION IS RECOMMENDED.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2010. WHEN THE PHYSICIAN INSERTED THE DEVICE, BLEEDING OCCURRED AT THE CAPTOR VALVE PORTION. (ABOUT 200ML). HOWEVER, THE PROCEDURE WAS CONDUCTED AS LABELED. NO PROBLEM TO THE PT WAS REPORTED.

    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 F2534303

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR