BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1233846 · Received November 12, 2008

    Report

    Report Number
    1820334-2008-00635
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    August 1, 2007
    Report Date
    October 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

    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 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 HYPERTENSION AND HOSTILE ABDOMEN AS WELL AS A PREVIOUS HISTORY OF CECITIS UNDERWENT AAA REPAIR IN 2007. THE PHYSICIAN COIL EMBOLIZED THE RIGHT INTERNAL ILIAC ARTERY. THE PROCEDURE PROCEEDED AS LABELED BUT AFTER THE DEPLOYMENT, CONFIRMATORY ANGIOGRAPHY REVEALED AN IPSILATERAL DISTAL TYPE I ENDOLEAK. THE IPSILATERAL DISTAL FIXATION SITE WAS REBALLOONED AND THE ENDOLEAK WAS REDUCED. THE ENDOLEAK PERSISTED SO THE PHYSICIAN DECIDED TO OBSERVE THE ENDOLEAK THROUGH FOLLOW-UP AND CONCLUDED THE PROCEDURE. ON TWENTY NINED DAYS LATER, CT CONFIRMED THAT THE ENDOLEAK HAD RESOLVED AT THE TIME OF DISCHARGE. PATIENT IS 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 F2008824

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention