BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1222093 · Received November 5, 2008

    Report

    Report Number
    1820334-2008-00609
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 9, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE ANATOMICAL REQUIREMENTS, WARNINGS, PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THE DEVICE REMAINS IMPLANTED AND NO IMAGES WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THAT THE EVENT WAS DUE TO ANATOMICAL CHANGES OVERTIME. HOWEVER, WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A MALE UNDERWENT INITIAL AAA REPAIR IN 2008. ONE FLEX MAIN BODY WAS PLACED AND THEN ONE ILIAC LEG GRAFT PLACED ON THE RIGHT AND TWO ILIAC LEG GRAFTS WERE PLACED ON THE LEFT SIDE. THE PATIENT'S RIGHT ILIAC BECAME MORE ANEURISMAL SO THE PHYSICIAN WENT IN SIX MONTHS LATER, AND COIL EMBOLIZED THE INTERNAL ILIAC AND EXTENDED THE EXTERNAL ILIAC BY PLACING ANOTHER ILIAC LEG GRAFTS. PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 1778842

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention