BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA LEG EXTENSION DELIVERY SYSTEM

    MDR report key: 1083281 · Received July 25, 2008

    Report

    Report Number
    1820334-2008-00415
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 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

    THE DEVICE REMAINS IMPLANTED, AND NO IMAGES RETURNED TO ASSIST IN THIS INVESTIGATION. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING ANATOMICAL REQUIREMENTS, WARNINGS, PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THE IFU ALSO ADVISES ON APPROPRIATE FOLLOW UP SO THAT LEAKS, SHOULD THEY OCCUR, BE IDENTIFIED AND ADDRESSED BEFORE CAUSING CLINICAL PROBLEMS. AN INTERNAL CLINICAL REVIEW INDICATED THAT THE EVENT WAS DUE TO USER ERROR AND INCORRECT PLANNING AND SIZING. HOWEVER, WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A FEMALE WITH ISCHEMIC HEART DISEASE AND HYPERTENSION AND MILD CALCIFICATION IN THE RIGHT COMMON ILIAC ARTERY, UNDERWENT AAA REPAIR IN 2008. THE PROCEDURE WENT AS LABELED. ON FINAL ANGIOGRAM, IT WAS NOTED THAT THERE WAS A CONTRALATERAL DISTAL TYPE I ENDOLEAK (1820334-2008-00414) THIS WAS RESOLVED BY PLACING ANOTHER MANUFACTURER'S STENT. A TYPE III ENDOLEAK WAS NOTED AT THE OVERLAP SITE OF THE MAIN BODY GRAFT AND THE ILIAC LEG GRAFT. THE AREA WAS BALLOON DILATED AT THE OVERLAP SITE ON BOTH SIDES. THE LEAKS WERE NOT COMPLETELY RESOLVED. THE PHYSICIAN OPTED TO OBSERVE THE ENDOLEAK. ALSO NOTED ON THE FINAL ANGIO WAS A SUSPECTED TYPE I ENDOLEAK AT THE PROXIMAL NECK SITE (1820334-2008-00413). THE PHYSICIAN BALLOONED THIS AREA, BUT DID NOT COMPLETELY RESOLVE THE LEAK, SO HE ELECTED TO WATCH THIS AS WELL. THE ENDOLEAKS NOT RESOLVED, SO THE PHYSICIAN ELECTED TO OBSERVE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA LEG EXTENSION DELIVERY SYSTEM MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2167606

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention