BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 4028071 · Received August 15, 2014

    Report

    Report Number
    1820334-2014-00389
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    February 26, 2013
    Report Date
    July 25, 2014
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION - UNKNOWN AS LOT IS UNKNOWN. IS THIS A SINGLE USE DEVICE: UNKNOWN AS NOT PROVIDED BY REPORTER. APPROXIMATE AGE OF DEVICE: UNKNOWN AS LOT IS UNKNOWN. DEVICE CODE: ENDOLEAKS ARE LABELED IN THE IFU. DEVICE MANUFACTURE DATE: UNKNOWN AS LOT IS UNKNOWN. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THIS (B)(6) MALE PATIENT IN THE SPIRAL-Z POST MARKET REGISTRY HAD A TYPE I ENDOLEAK AT THE CONCLUSION OF THE DEPLOYMENT PROCEDURE ON (B)(6) 2013. THE PATIENT WAS BEING TREATED FOR A 8.2 CM AORTIC ANEURYSM. THE PROXIMAL NECK HAD AN IRREGULAR SHAPE WITH NO PLAQUE/THROMBUS. BOTH ILIAC ARTERIES HAD MODERATE TORTUOSITY, BUT NO OCCLUSIVE DISEASE OR CALCIFICATION. THE PATIENT RECEIVED A MAIN-BODY DEVICE, RIGHT AND LEFT ILIAC LEGS, AND A LEFT ILIAC LEG EXTENSION. A MAIN BODY EXTENSION WAS ALSO USED BUT THE LOCATION WAS NOT MARKED. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE COMPONENTS. NO OTHER DEVICES WERE PLACED AND NO OTHER PROCEDURES WERE PERFORMED. A MOLDING BALLOON WAS USED BUT NO DETAILS WERE PROVIDED REGARDING ITS USE. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICE WAS PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, OR THROMBUS. A DISTAL TYPE I ENDOLEAK ON THE LEFT WAS NOTED. THE 1-TO-6 MONTH FOLLOW UP IMAGING WAS DONE ON (B)(6) 2013 (64 DAYS POST-PROCEDURE) AND SHOWED THAT THE DEVICE WAS PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, THROMBUS, OR ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491181 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other