BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1903533 · Received November 19, 2010

    Report

    Report Number
    1820334-2010-00520
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 19, 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 DEVICE REMAINS IMPLANTED AND NO IMAGES WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. 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 THE DEVICE IS INTENDED FOR PATIENTS THAT HAVE <60 DEGREE ANGLE BETWEEN THE PROXIMAL NECK AND THE LONG AXIS OF THE ANEURYSM. THE COMPLAINT CORRESPONDENCE INDICATED THAT THE PATIENT WAS NOT SUITABLE FOR EVAR BECAUSE OF ANATOMICAL EXCLUSION. PATIENT ANATOMY LIKELY RESULTED IN THE REPORTED ENDOLEAK. AT THIS TIME, THERE IS NO INDICATION THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE DEVICE RESULTED IN THE REPORTED ENDOLEAK. 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) FEMALE PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PATIENT'S ANATOMICAL FORM WAS NOT SUITABLE FOR AAA REPAIR SINCE THE ANGLE OF PROXIMAL NECK TO THE LONG AXIS OF ANEURYSM WAS MORE THAN 90 DEGREES. THE PROCEDURE WAS PERFORMED AS PRESCRIBED. FINAL CONFIRMATORY ANGIOGRAPHY REVEALED AN ENDOLEAK, HOWEVER, THE PROCEDURE WAS COMPLETED SINCE THE ENDOLEAK WAS THOUGHT TO BE TYPE II. ON (B)(6) 2010, IT WAS CONFIRMED THE ENDOLEAK REMAINED UNDER ECHO. DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED IT WAS A PROXIMAL TYPE I ENDOLEAK. ANOTHER MANUFACTURER'S STENTS WERE PLACED AT THE PROXIMAL SEAL SITE AND THE ENDOLEAK WAS RESOLVED. THEN THE PROCEDURE WAS COMPLETED. THE PATIENT IS FINE.

    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 F2535318

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention