BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1202994 · Received October 17, 2008

    Report

    Report Number
    1820334-2008-00583
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 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 USER ERROR IN THAT THE PT WAS OUTSIDE OF THE INDICATIONS FOR USE. 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 PULMONARY DISEASE, RENAL DISEASE, CEREBROVASCULAR DISEASE, ISCHEMIC HEART DISEASE AND PREVIOUS HISTORY OF HYPERTENSION UNDERWENT ENDOVASCULAR THERAPY IN 2008. THE PT'S ANATOMIC FORM WAS NOT SUITABLE FOR AAA REPAIR BECAUSE OF AN ANGLE MORE THAN 60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM. THE PROCEDURE WENT AS LABELED, BUT ANGIOGRAPHY CONFIRMED A TYPE I ENDOLEAK FORM THE PROXIMAL NECK. THE ENDOLEAK WAS RESOLVED BY PLACING MFR'S STENT. PT HAS RECOVERED.

    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 F2184535

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention