BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1993435 · Received February 8, 2011

    Report

    Report Number
    1820334-2011-00078
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) BLOOD LOSS IS LABELED IN THE IFU. VALVE LEAKS ARE NOT SPECIFICALLY ADDRESSED IN THE IFU. THE PRODUCT WAS RETURNED IN A USED AND CONTAMINATED CONDITION. CHECK-FLO DISCS CRITICAL DIMENSIONS ARE INSPECTED DURING INCOMING QUALITY CONTROL. INSPECTION OF CAPTOR VALVE ASSEMBLY PERFORMED 100% UNLESS OTHERWISE SPECIFIED. THE VALVE COLLAR IS VERIFIED TO BE COMPLETELY SNAPPED INTO THE VALVE CHAMBER. THE ORIENTATION OF THE CHECK-FLO DISCS ARE CONFIRMED. THE DISCS ARE ALSO EXAMINED TO VERIFY THAT EACH IS PUNCTURED AND FREE OF TEARS. (B)(4). 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 INSTRUCTION FOR USE (IFU) DESCRIBING THE APPROPRIATE WARNINGS AND PRECAUTIONS, CONTRAINDICATIONS, AND THE PROPER DEPLOYMENT PROCEDURE. THE DEVICE WAS EXAMINED WITH THE ASSISTANCE OF ENGINEERING; WHICH REVEALED THAT THE CAPTOR VALVE WAS FUNCTIONAL. THE DEVICE WAS LEAK TESTED WITH AND WITHOUT A POSITIONER THROUGH THE CHECK FLO DISCS AND THE CAPTOR VALVE OPENED AND CLOSED. THE VALVE LEAKED THROUGH THE DISCS AND IRIS VALVE IN EACH CONDITION. THERE WAS ONE TEAR AND ONE MINOR TEAR IN THE WEBBING OF THE DISCS. 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). BASED ON RISK ASSESSMENT, RISK REDUCTION IS RECOMMENDED. ENGINEERING IS CURRENTLY EVALUATING AREAS FOR IMPROVEMENT.

    Description of Event or Problem · 1

    AN (B)(6) MALE PT UNDERWENT ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2011. DURING PLACEMENT OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, THE PHYSICIAN BEGAN ENCOUNTERING DIFFICULTIES CONCERNING THE HEMOSTATIC VALVE ON THE DEVICE. AS SOON AS THE PHYSICIAN HAD THE DEVICE PLACED IN THE PT, LARGE AMOUNTS OF BLOOD BEGAN TO EXIT THE HEMOSTATIC VALVE. THE AREA REP RECOMMENDED PLACING THE VALVE IN THE OFF POSITION EVEN THOUGH THE GRAY POSITIONER WAS IN PLACE. THIS ACTION ASSISTED IN SLOWING THE BLOOD'S EXIT THROUGH THE VALVE. THE PT ULTIMATELY EXPERIENCED AN APPROX LOSS OF 6700 CCS OF BLOOD. NO TRANSFUSION PERFORMED DURING THE CASE. REP WAS NOT AWARE OF TRANSFUSION EVER OCCURRING FOLLOWING THE CASE. PT'S BLOOD PRESSURE AND HEART RATE DID NOT CHANGE DURING THE LOSS OF BLOOD.

    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 2445315

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other