BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1850456 · Received September 21, 2010

    Report

    Report Number
    1820334-2010-00481
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    COOK INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIFFICULT TO REMOVE IS ADDRESSED IN THE PROVIDED PHYSICIAN REFERENCE MANUAL. NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST WITH THIS INVESTIGATION. THE DEVELOPMENT OF THE ZENITH DEVICE FOLLOWED AND SUCCESSFULLY COMPLETED ALL VERIFICATION AND VALIDATION ACTIVITIES SHOWING THE DEVICE MET THE DESIGN REQUIREMENTS AND THAT THE REQUIREMENTS MET THE NEEDS OF THE USER. EACH DEVICE IS SHIPPED WITH AN IFU DESCRIBING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AS WELL AS THE CORRECT DEPLOYMENT PROCEDURE. A PHYSICIAN REFERENCE MANUAL IS AVAILABLE TO ALL USING PHYSICIANS, WHICH LISTS TROUBLESHOOTING TECHNIQUES THAT, IF FOLLOWED, COULD REDUCE THE OCCURRENCE OR REDUCE THE LIKELIHOOD OF THE WORSE CASE SEVERITY OCCURRING FROM THIS FAILURE MODE. THE PROXIMAL TRIGGER WIRE CONTAINS AN ETCH MARK THAT IS SPECIFIED TO BE AT A CERTAIN LOCATION RELATIVE TO THE TOP CAP. LOCATION OF THIS ETCH MARK IS VERIFIED ON EACH DEVICE. A CHANGE REQUEST IMPLEMENTED CHANGES TO THE LOADING PROCEDURES THAT WILL POSSIBLY PREVENT DAMAGE TO THE TRIGGER WIRE. AN ALTERNATE DEPLOYMENT SEQUENCE HAS BEEN APPROVED AND DISTRIBUTED TO USING PHYSICIANS REGARDING DIFFICULTY IN REMOVING THE PROXIMAL TRIGGER WIRE. THIS DEPLOYMENT SEQUENCE WILL ENABLE THE PHYSICIAN TO REPOSITION THE TOP CAP WITH RESPECT TO THE SUPRARENAL STENT AND SUBSEQUENTLY RELEASING TENSION FROM THE TRIGGER WIRE ALLOWING IT TO BE REMOVED. THIS WAS DONE ON A CHANGE REQUEST AND WAS EFFECTIVE ON (B)(4) 2009. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED OR REPORTED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR INCIDENTS.

    Description of Event or Problem · 1

    THE TRIGGER WIRE BECAME COMPRESSED BETWEEN THE STENT AND THE TOP CAP, MAKING IT DIFFICULT TO REMOVE. THE AREA REPRESENTATIVE ALSO STATED THE PHYSICIAN MENTIONED THIS STATEMENT TO HIM TWICE. "IN TWO CASES THE CONTRALATERAL GATE DOES NOT LINE UP WITH THE SIDE PORT ON THE CAPTOR VALVE." PATIENT'S OUTCOME/CONDITION WAS REQUESTED BUT NOT PROVIDED.

    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 2381034

    Patients

    Seq Age Sex Outcome Treatment
    1