BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1905733 · Received November 22, 2010

    Report

    Report Number
    1820334-2010-00575
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 20, 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). THE ZENITH DEVICE HAS COMPLETED DESIGN CONTROL REQUIREMENTS SHOWING THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO ENDOLEAKS, THE IFU LISTS SEVERAL WARNINGS/PRECAUTIONS THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING OR LESSEN THE ASSOCIATED EFFECTS; ANATOMICAL CRITERIA, ANATOMICAL CONDITIONS, PROPER BALLOONING SITES, FOLLOW-UP GUIDELINES, THE IMPORTANCE OF AN ACCURATE DEPLOYMENT. SPECIFICALLY, THE IFU STATES THAT THE DEVICE IS INTENDED FOR PATIENTS WITH LESS THAN A <60 DEGREE ANGLE BETWEEN THE INFRARENAL NECK AND THE LONG AXIS OF THE ANEURYSM. THE COMPLAINT CORRESPONDENCE INDICATED THAT THE PT WAS NOT SUITABLE FOR EVAR DUE TO ANATOMICAL EXCLUSION. PT ANATOMY LIKELY RESULTED IN THE REPORTED TYPE 1A ENDOLEAK. THE ENDOLEAK WAS REDUCED WITH PLACEMENT OF AN ADDITIONAL STENT GRAFT. AT THIS TIME, THERE IS NO INDICATION THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE DEVICE RESULTED IN THE ENDOLEAK. AS WITH ALL ENDOLEAKS, IT IS IMPORTANT THAT THE TREATING PHYSICIAN FOLLOW THE PATIENT'S ENDOLEAK APPROPRIATELY, AND PROVIDE FURTHER TREATMENT IF THE PHYSICIAN FEELS THE PT IS AT RISK OF ONGOING SAC PRESSURIZATION, ANEURYSM GROWTH, AND POSSIBLE RUPTURE. 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 THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL WITH INCLUSION OF THE EVENT. RISK MITIGATION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PATIENT'S ANATOMICAL FORM WAS NOT SUITABLE FOR AAA REPAIR SINCE THE ANGLE OF PROXIMAL NECK WAS MORE THAN 70 DEGREES TO THE LONG AXIS OF THE ANEURYSM. FINAL ANGIOGRAPHY REVEALED A PROXIMAL TYPE I ENDOLEAK. THE BODY EXTENSION WAS PLACED. THE PROCEDURE WAS COMPLETED SINCE THE ENDOLEAK WAS ALMOST RESOLVED. THE PATIENT'S CONDITION AFTER THE PROCEDURE IS UNKNOWN.

    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 F2534294

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention