BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 6682293 · Received June 30, 2017

    Report

    Report Number
    1820334-2017-01418
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    May 31, 2017
    Report Date
    November 17, 2017
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    10827002484235
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DEVICE IS NOT AVAILABLE FOR EVALUATION AND HAS BEEN DISCARDED.

    Additional Manufacturer Narrative · 1

    510(K) P020018. INVESTIGATION: A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, TRENDS, AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS NOT RETURNED; THEREFORE, DEVICE FAILURE ANALYSIS AND PHYSICAL EXAMINATION OF THE DEVICE USED IN THIS CASE COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT THE A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY; DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING AND QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE AVAILABLE INFORMATION AND THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED OR REPORTED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE USING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, THE PHYSICIAN AND REPRESENTATIVE BELIEVE THAT THERE WAS A SUTURE HOLE IN THE FIRST SEAL STENT OF THE GRAFT. A LEAK OF CONTRAST WAS SEEN OUTSIDE OF THE GRAFT WHERE A SUTURE HOLE WOULD BE. A CUFF WAS ADDED TO COVER THE HOLE AND THE LEAK WAS NO LONGER PRESENT. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE PRODUCT CAUSED OR CONTRIBUTED TO THE NEED FOR AN ADDITIONAL PROCEDURE. AN ADDITIONAL CUFF WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463655 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA 10827002484235

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention