BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2042121 · Received March 30, 2011

    Report

    Report Number
    1820334-2011-00148
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 28, 2011
    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

    TWO STATIC IMAGES WERE RETURNED TO ASSIST IN THIS INVESTIGATION. NUMEROUS DESIGN VERIFICATION AND VALIDATION ACTIVITIES HAVE BEEN PERFORMED TO ENSURE THAT THIS DEVICE MEETS DESIGN REQUIREMENTS, AND THAT THE DEVICE MEETS THE NEEDS OF THE USER. IN ADDITION, THE IFU FOR THE ZENITH LINE OF PRODUCTS LISTS SEVERAL KEY POINTS THAT COULD ELIMINATE THIS FAILURE MODE FROM OCCURRING. ANATOMICAL CRITERIA, PT SIZING, PROPER AMOUNT OF OVERLAP BETWEEN COMPONENTS, PT F/U GUIDELINES, ETC. PER THE SUPPLIED INSTRUCTIONS FOR USE (IFU), THE ZENITH FLEX AAA ENDOVASCULAR GRAFT IS A MODULAR SYSTEM CONSISTING OF THREE COMPONENTS, A BIFURCATED AORTIC MAIN BODY AND TWO ILIAC LEGS. THE SYSTEM IS INDICATED FOR ENDOVASCULAR TREATMENT OF PTS WITH ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS HAVING MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR. THE COMPLAINT DEVICE WAS USED OFF-LABEL TO TREAT A RIGHT COMMON AND RIGHT INTERNAL ILIAC ANEURYSM. THE COMPLAINT DEVICE DEPLOYED UNACCOMPANIED BY THE MAINBODY AND ADDITIONAL ILIAC LEG GRAFT. REVIEW OF THE TWO STATIC IMAGES THAT WERE RETURNED WAS INCONCLUSIVE IN CLASSIFYING THE ENDOLEAK. ADDITIONAL IMAGING, INCLUDING CT SCANS AND RUNNING FLUOROSCOPY, WOULD BE BENEFICIAL IN DETERMINING THE ETIOLOGY OF THE ENDOLEAK. THE ENDOLEAK IS LIKELY A TYPE II AT THE INTERNAL ILIAC. 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

    ON (B)(6) 2011, A (B)(6) YR OLD FEMALE PT UNDERWENT RIGHT COMMON AND RIGHT INTERNAL ILIAC ARTERY ANEURYSM REPAIR. THE PT'S ANATOMY WAS NOT NOTABLY TORTUOUS OR CALCIFIED. ONLY A ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG WAS PLACED IN THE RIGHT COMMON ILIAC ARTERY. ANGIOPLASTY AFTER BALLOONING CONFIRMED AN ENDOLEAK AND IT WAS NOT SOLVED BY ADDITIONAL BALLOONING. ANGIOGRAPHY INSIDE THE STENT GRAFT SHOWED INTERROGATE LEAK FROM THE GRAFT FABRIC WHICH SEEMED TO BE A TYPE III OR TYPE IV, SO THE PHYSICIAN PLACED ANOTHER MFR'S ENDOPROSTHESIS INSIDE THE ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG. THE REMAINING LEAK WAS DETERMINED AS A TYPE II AND THE PROCEDURE WAS COMPLETED. THE FINAL ACT REVEL WAS 144. THE PT WAS DOING FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. N/A 2502902

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention