BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2140354 · Received June 16, 2011

    Report

    Report Number
    1820334-2011-00311
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 24, 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

    NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE INVESTIGATION AT THIS TIME. 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. THE IFU STATES, "TO AVOID ANY TWIST IN THE ENDOVASCULAR GRAFT, DURING ANY ROTATION OF THE DELIVERY SYSTEM, BE CAREFUL TO ROTATE ALL OF THE COMPONENTS OF THE SYSTEM TOGETHER (FROM OUTER SHEATH TO INNER CANNULA)." BY REPORT, THE PHYSICIAN INTENTIONALLY TWISTED THE GRAFT DUE TO TORTUOUS PATIENT ANATOMY. THIS RESULTED IN OCCLUSION OF THE LEFT LIMB AND THE LIMB COULD NOT BE CANNULATED. PATIENT WAS CONVERTED TO AORTO-UNI-ILIAC WITH A GOOD OUTCOME. 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, PATIENT, UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR, BUT THE TERMINAL AORTA AND A COMMON ILIAC ARTERY WERE HIGHLY TORTUOUS. TO STRAIGHTEN THE LEFT ILIAC ARTERY, THE PHYSICIAN TWISTED A MAINBODY SLIGHTLY AND DEPLOYED. THE TWIST CAUSED THE LEFT LIMB TO BE PRESSED BY THE MAINBODY DELIVERY SYSTEM AND THE AORTA WALL, AND IT PREVENTED CANNULATION OF THE LEFT LIMB. THUS THE PHYSICIAN PLACED THE RIGHT ILIAC LEG GRAFT FIRST, AND ATTEMPTED TO APPROACH THE LEFT LIMB FROM THE RIGHT FEMORAL, BUT FAILED BECAUSE THE LEFT LIMB WAS COMPLETELY CLOSED TO LET THE WIREGUIDE GO THROUGH THE MAINBODY. HE DECIDED TO GIVE UP ON CANNULATION OF THE LEFT SIDE AND PLACED A CONVERTER AND OCCLUDED THE LEFT SIDE WITH AN ILIAC PLUG. SUBSEQUENTLY FEM-FEM BYPASS WAS PERFORMED AND GOOD PULSATION ON BOTH LEGS WAS CONFIRMED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DOING FINE AFTER THE PROCEDURE.

    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 F2605295

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention