BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3760970 · Received April 10, 2014

    Report

    Report Number
    1820334-2014-00168
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 20, 2014
    Manufacturer
    COOK INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT WEIGHT: UNKNOWN AS NOT PROVIDED BY REPORTED.(B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLE MALE PATIENT IS IN (B)(4) POST-MARKET REGISTRY AND UNDERWENT DEPLOYMENT OF A MAIN BODY AND RIGHT AND LEFT ILIAC LEGS ON (B)(6) 2014 FOR TREATMENT OF A 46 MM AAA. THE PROXIMAL NECK WAS PARALLEL IN SHAPE AND HAD COMPLETE NECK PLAQUE/THROMBUS. THE LEFT ILIAC ARTERY HAD NO OCCLUSIVE DISEASE, MILD CALCIFICATION, AND MILD TORTUOSITY. THE LEFT ILIAC INNER DIAMETER AT THE AORTIC BIFURCATION WAS 11 MM AND THE INNER DIAMETER OF THE LEFT ILIAC AT THE NARROWEST SEGMENT ALONG THE INTENDED DELIVERY PATH WAS 10 MM. THE COMPLETION ANGIOGRAM SHOWED THAT THE DEVICES WERE PATIENT WITHOUT EVIDENCE OF EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, THROMBUS, OR ENDOLEAKS. LATER ON THE SAME DAY, THE PATIENT WAS SHOWING CLINICAL SIGNS INDICATIVE OF LOWER EXTREMITY ISCHEMIA. THE LEFT ILIAC LEG WAS SHOWN TO HAVE THROMBOSIS WITH 100% STENOSIS AND UNDERWENT THROMBECTOMY (1820334-2014-00166). ON (B)(6) 2014, (ONE DAY POST-PROCEDURE), THE PATIENT WAS SHOWING CLINICAL SIGNS INDICATIVE OF LOWER EXTREMITY ISCHEMIA (1820334-2014-00168). THE RIGHT ILIAC LEG WAS SHOWN TO HAVE COMPRESSION WITH 70% STENOSIS AND WAS TREATED WITH ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216369 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC. NA 4747282

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other