BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2140321 · Received June 16, 2011

    Report

    Report Number
    1820334-2011-00309
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 23, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGES WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. CHECK-FLO DISCS CRITICAL DIMENSIONS ARE INSPECTED DURING INCOMING QUALITY CONTROL. AN 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 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. 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 QERA, RISK REDUCTION IS RECOMMENDED. A CAPA IS CURRENTLY OPEN AND ADDRESSES THIS FAILURE MODE.

    Description of Event or Problem · 1

    MARKERS ON THE DEVICE APPEARED IN AN UNUSUAL MANNER AND DID NOT CLEARLY DEFINE LIMIT OF COVERED STENT (1820334-2011-00308). THIS MADE POSITIONING THE DEVICE DIFFICULT AND CREATED CONCERN ABOUT COVERING THE RENAL ARTERY. ALSO, WITH THE SAME DEVICE, THE CAPTOR VALVE LEAKED LARGE AMOUNTS OF BLOOD, EVEN IN THE CLOSED POSITION (1820334-2011-00309). NO HARM TO PATIENT REPORTED. PROCEDURE WAS COMPLETED AND DEVICE REMAINS INSITU. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED 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 2696871

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other