BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2132212 · Received June 14, 2011

    Report

    Report Number
    1820334-2011-00289
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 17, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SHEATH ASSEMBLY WAS RETURNED TO ASSIST IN THIS INVESTIGATION. CHECK-FLO DISCS CRITICAL DIMENSIONS ARE INSPECTED DURING INCOMING QUALITY CONTROL, INSPECTING CAPTOR VALVE ASSEMBLY (PERFORMED 100% UNLESS OTHERWISE SPECIFIED); VALVE COLLAR VERIFIED TO BE COMPLETELY SNAPPED INTO THE VALVE CHAMBER AND THE ORIENTATION OF THE CHECK-FLO DISC ARE CONFIRMED. IT IS ALSO VERIFIED THAT THE DISCS ARE PUNCTURED AND FREE OF TEARS. (B)(4). 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 DEVICE WAS RETURNED TO ASSIST IN THIS INVESTIGATION. THE IRIS VALVE COULD BE OPENED AND CLOSED. AIR AND CIDEX SOLUTION WERE EXPELLED FROM THE VALVE WHEN ROTATING THE IRIS VALVE. THERE WAS ONE SMALL TEAR IN THE WEBBING OF THE DISCS. THE VALVE WAS LEAK TESTED USING A 20CC SYRINGE AND WATER. THE VALVE DID NOT LEAK WITH THE POSITIONER THROUGH THE VALVE. THE POSITIONER WAS REMOVED. THE VALVE LEAKED THROUGH THE IRIS VALVE WITH THE IRIS VALVE OPEN. THE IRIS VALVE WAS THEN CLOSED AND THE VALVE SPRAY LEAKED THROUGH THE IRIS VALVE AND AIR CAME OUT BETWEEN THE VALVE COLLAR AND VALVE CONTROL FOR SEVERAL SECONDS. THEN THE DEVICE DID NOT LEAK. IT IS POSSIBLE THAT PRESSURE ADJUSTED THE POSITION OF THE DISC. THE VALVE WAS DISASSEMBLED AND THE CHECK-FLO DISCS AND IRIS VALVE WERE EXAMINED. EACH DISC WAS TORN. THE IRIS VALVE WAS UNREMARKABLE. TEARS IN THE DISC LIKELY RESULTED IN VALVE LEAKAGE. WE ARE AWARE OF THE POTENTIAL FOR LEAKAGE THROUGH THE VALVE AND THE RISK ASSOCIATED WITH THIS FAILURE MODE. A CAPA FOR THIS FAILURE MODE IS CURRENTLY OPEN. 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 (QERA) AND BASED ON RISK ASSESSMENT PER THE QERA, RISK REDUCTION IS RECOMMENDED. A CAPA IS CURRENTLY OPEN AND ADDRESSES THIS FAILURE MODE.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR THE ENDOVASCULAR REPAIR. A LEFT ILIAC LEG WAS APPROACHED FROM LEFT COMMON FEMORAL ARTERY. (ACT: MORE THAN 200). AFTER LEFT ILIAC LEG PLACEMENT, THE PHYSICIAN WITHDREW GREY POSITIONER WITH AUS WIRE GUIDE REMAINED AND CLOSED THE CAPTOR HEMOSTATIC VALVE. THEN, BLOOD LEAKAGE FROM THE CAPTOR HEMOSTATIC VALVE WAS CONFIRMED. OTHER MANUFACTURER'S SHORT SHEATH (7FR / 10CM) WHICH WAS USED BEFORE MAIN BODY PLACEMENT WAS INSERTED IN CAPTOR HEMOSTATIC VALVE OVER THE AUS WIRE GUIDE, THEN THE LEAKAGE WAS STOPPED. BALLOONING WAS PERFORMED WITH CODA AFTER RIGHT ILIAC LEG PLACEMENT, AND THE BALLOON WAS KEPT INSIDE OF THE LEFT ILIAC LEG SHEATH TO PREVENT BLOOD LEAKAGE. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2608651

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR