BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 3911606 · Received June 27, 2014

    Report

    Report Number
    1820334-2014-00290
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 11, 2014
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT WITH AAA UNDERWENT EVAR ON (B)(6) 2014. ACCESS AT UPPER FEMORALS, DEVICE PLACED JUST BELOW RENALS TO JUST ABOVE AORTIC BIFURCATION. EXTENDED INTO LEFT EXTERNAL ILIAC WITH TWO 13MM ZENITH SPIRAL-Z LIMBS (ZSLE'S), AND AN IBD PLACED ON THE RIGHT. AT THE END OF THE CASE A LEAK WAS EVIDENT ON THE LEFT SIDE. IT'S ORIGIN WAS INCONCLUSIVE. AFTER A FOLLOW UP SCAN AND CLOSER INSPECTION IT IS FELT IT MAY BE A TYPE 3 ENDOLEAK THROUGH THE ZSLE'S ON THE LEFT SIDE. ALL GRAFTS REMAIN IMPLANTED. A SECONDARY PROCEDURE TO RELINE THE GRAFTS THOUGHT THE LEFT COMMON ILIAC, INTO THE LEFT EXTERNAL ILIAC IS PLANNED. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION FROM THE REP WAS PROVIDED ON (B)(4) 2014: THE TWO CONTRALATERAL LEG EXTENSIONS WERE USED TO BRIDGE THE DISTANCE BETWEEN THE MAIN BODY AND THE PROXIMAL LEFT EXTERNAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376288 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 4699342

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention