BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 3232290 · Received July 10, 2013

    Report

    Report Number
    1820334-2013-00270
    Event Type
    Injury
    Date Received
    July 10, 2013
    Report Date
    June 18, 2013
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT AND DEVICE CODES: ANEURYSM GROWTH IS LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PT WITH SOME CALCIUM AND TORTUOSITY UNDERWENT EVAR ON (B)(6) 2006. THE ENDOGRAFTS (1 MAIN BODY AND TWO ILIAC LEG GRAFTS) WERE PLACED WITH NO COMPLICATIONS. THE PT WAS OBSERVED WITH FOLLOW-UP FOR SEVERAL YEARS WITHOUT ISSUES. ON (B)(6) 2011, DUE TO SAC ENLARGEMENT A SELECTIVE ANGIOGRAM WAS PERFORMED SHOWING TYPE 2 LUMBAR ENDOLEAK. ON (B)(6) 2011, A COIL EMBOLIZATION WAS PERFORMED OF THE LUMBAR ARTERIES. NOW THE PT PRESENTS WITH ENLARGED ANEURYSM SAC WITH NO EVIDENCE OF ENDOLEAK. ON (B)(6) 2013, THE DOCTOR PLANS TO PERFORM AN ANGIOGRAM AND PLANS TO RELINE THE EXISTING GRAFT. THE PT IS STABLE AND FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319091 ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 1729289

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR