BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1193289 · Received October 7, 2008

    Report

    Report Number
    1820334-2008-00559
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    COOK INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU LISTING 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 THE EVENT WAS DUE TO PATIENT ANATOMY. HOWEVER, WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS, AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A MALE WITH ANATOMICAL FORM SUITABLE FOR ENDOVASCULAR REPAIR UNDERWENT EVAR IN 2008. THE PROCEDURE PROGRESSED AS LABELED. CONFIRMATORY ANGIOGRAPHY REVEALED A DISTAL TYPE I ENDOLEAK IN THE IPSILATERAL ILIAC LEG GRAFT. THE PHYSICIAN CONSIDERED THAT THIS RESULTED FROM INCOMPLETE SEALING OF THE ILIAC LEG GRAFT. AN ADDITIONAL ILIAC LEG GRAFT WAS PLACED EXTENDING THE LANDING ZONE ABOUT 10MM. THE ENDOLEAK WAS REDUCED, BUT NOT RESOLVED. HOWEVER, THE PHYSICIAN THOUGHT THE ENDOLEAK WOULD SEAL ITSELF AFTER THE HEPARIN WAS REVERSED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    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 F2167894

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention