BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1915640 · Received December 3, 2010

    Report

    Report Number
    1820334-2010-00620
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 1, 2010
    Manufacturer
    COOK INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE INVESTIGATION. CHECK-FLO DISCS CRITICAL DIMENSIONS ARE INSPECTED DURING INCOMING QUALITY CONTROL. PER QUALITY CONTROL SPECIFICATION, INSPECTION OF CAPTOR VALVE ASSEMBLY PERFORMED 100% UNLESS OTHERWISE SPECIFIED. (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. LEAKAGE AT THE CAPTOR VALVE RESULTED IN BLOOD LOSS THAT REQUIRED BLOOD TRANSFUSION. DAMAGE TO THE CHECK-FLO DISCS AND VALVE COLLAR LIKELY RESULTED IN LEAKAGE. WE ARE AWARE OF THE POTENTIAL FOR LEAKAGE THROUGH THE CAPTOR VALVE AND THE RISK ASSOCIATED WITH THIS FAILURE MODE. ENGINEERING IS CURRENTLY EVALUATING AREAS FOR IMPROVEMENT REGARDING THE CAPTOR VALVE. THE RISK OF BLOOD LOSS REMAINS WITH THE USE OF A DEVICE WITH A CAPTOR VALVE. MEASURES ARE BEING TAKEN TO ADDRESS THIS FAILURE MODE. 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).

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATED: A (B)(6) MALE PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PHYSICIAN PERFORMED THE PROCEDURE AS LABELED EXCEPTED GET DEPLOYED THE TOP CAP. DURING REMOVE THE GRAY POSITIONER AND REMOVED THE DELIVERY SYSTEM OF THE IPSILATERAL LEG, THE PHYSICIAN RECOGNIZED THE BLEEDING AT THE CAPTOR VALVE PORTION. SO THE PHYSICIAN INSERTED THE 8FR SHEATH INTO THE VALVE PORTION, BUT IT COULD NOT BE STOP THE BLEEDING. THE PHYSICIAN DID TRANSFUSE FOR IN CASE AND ENDED THE PROCEDURE. THERE WERE NO PATIENT PROBLEMS AS A RESULT OF THIS EVENT.

    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 F2563555

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention