BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1222091 · Received November 5, 2008

    Report

    Report Number
    1820334-2008-00627
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 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. NO PRODUCT WAS RECEIVED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THE EVENT WAS POSSIBLY DUE TO PRODUCT QUALITY. WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND HAVE TAKEN ACTION TO RETRAIN PHYSICIANS IN ANOTHER COUNTRY, AS OF 2008, WHO ARE USING IS DEVICE IN AN EFFORT TO REDUCE ISSUES OF THIS NATURE. WE WILL ALSO CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A MALE HAD AN ANATOMICAL FORM THAT WAS CONSIDERED SUITABLE FOR AAA REPAIR, UNDERWENT ENDOVASCULAR THERAPY IN 2008. THE SUPRARENAL STENT WAS DEPLOYED FIRST, THEN THE CANNULATION OF THE CONTRALATERAL LIMB WAS PERFORMED. AFTER DEPLOYMENT OF THE MAIN BODY, BLOOD LEAKAGE OCCURRED WHEN THE GREY POSITIONER WAS REMOVED. BLOOD WAS ALMOST SPURTING FROM THE VALUE. TOTAL HEMORRHAGE VOLUME WAS 700CC. BLOOD TRANSFUSION OF 250CC WAS PERFORMED. THE PATIENT DID NOT SHOW ANY POST PROCEDURE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2173827

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention