BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION

    MDR report key: 1211129 · Received October 23, 2008

    Report

    Report Number
    1820334-2008-00605
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 ASSESSMENT INDICATED THE EVENT WAS DUE TO USER ERROR IN THAT THERE WAS IMPROPER PLANNING AND SIZING. WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS OF THIS MATTER AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A MALE UNDERWENT INITIAL AAA REPAIR IN 2007. ONE FLEX MAIN BODY, TWO ILIAC LEG GRAFTS, AND ONE MAIN BODY EXTENSION GRAFT WERE PLACED. THE MAIN BODY EXTENSION WAS USED TO EXTEND THE SEAL ON THE RIGHT SIDE. THEN IN 2008, DUE TO A DISTAL TYPE I ENDOLEAK FROM THE MAIN BODY EXTENSION, THE PHYSICIAN PLACED AN ADDITIONAL ILIAC LEG GRAFT TO SUCCESSFULLY REPAIR THE ENDOLEAK. PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 1717261

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention