BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2211304 · Received August 3, 2011

    Report

    Report Number
    1820334-2011-00402
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BLOODLOSS IS LABELED IN THE IFU. VALVE LEAKAGE IS NOT SPECIFICALLY ADDRESSED IN THE IFU. THE SHEATH ASSEMBLY WAS RETURNED IN A USED AND CONTAMINATED CONDITION. CHECK-FLO DISCS CRITICAL DIMENSIONS ARE INSPECTED DURING INCOMING QUALITY CONTROL (QC). AN INSPECTION OF THE CAPTOR VALVE ASSEMBLY 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 ALSO EXAMINED TO VERIFY THAT EACH IS PUNCTURED AND FREE OF TEARS. A 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 IRIS VALVE COULD NOT BE OPENED AND CLOSED WHEN ROTATING THE VALVE CONTROL. THE TOP FLANGE WAS DISLODGED. MOVEMENT OF THE POSITIONER WHILE THE IRIS VALVE IS CLOSED MAY HAVE RESULTED IN DISLODGEMENT OF THE IRIS. THERE WAS ONE TEAR IN THE WEBBING OF THE DISC WITH THE POSITIONER THROUGH THE VALVE. THE DEVICE WAS LEAK TESTED USING A 20CC SYRINGE AND WATER. THE DEVICE LEAKED BETWEEN THE VALVE CONTROL AND COLLAR WITH AND WITHOUT A DILATOR THROUGH THE VALVE. THE LEAK STOPPED WITHOUT THE POSITIONER THROUGH THE VALVE AND AS ADDITIONAL PRESSURE WAS APPLIED. THE POSITIONER WAS REINSERTED AND THE DEVICE LEAKED THROUGH THE IRIS VALVE. THE POSITIONER WAS THEN REMOVED AND THE DEVICE LEAKED THROUGH THE IRIS VALVE AFTER SUBSTANTIAL PRESSURE WAS APPLIED TO THE SYSTEM. THERE WAS BIOLOGICAL MATTER INSIDE THE VALVE COLLAR, INDICATING THAT THE DEVICE LEAKED OUTSIDE OF THE IRIS VALVE. THE VALVE WAS DISASSEMBLED. 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. A CAPA HAS BEEN INITIATED IN REGARD TO 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) AND BASED ON RISK ASSESSMENT PER QERA, RISK REDUCTION IS RECOMMENDED. CAPA IS CURRENTLY OPEN AND ADDRESSES THIS FAILURE MODE.

    Description of Event or Problem · 1

    A MALE PATIENT UNDERWENT EVAR ON (B)(6) 2011. THIS DEVICE HAS BEEN CORRECTLY PREPARED PRIOR TO USE. TOWARDS THE END OF THE PROCEDURE A STEADY TRICKLE OF BLOOD WAS NOTED COMING THROUGH THE CAPTOR VALVE. A METAL CLAMP WAS PLACED ON THE SHEATH TO PREVENT FURTHER LOSS AS A SMALLER SHEATH WAS PREPARED FOR INTRODUCTION INTO THE DEVICE. THE SHEATH FROM THE TFFB WAS REMOVED AS SOON AS POSSIBLE. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

    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 2751617

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK