BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH AAA MAIN BODY GRAFT

    MDR report key: 855737 · Received May 25, 2007

    Report

    Report Number
    1820334-2007-00127
    Event Type
    Death
    Date Received
    May 25, 2007
    Date of Event
    April 17, 2007
    Report Date
    April 27, 2007
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: NO PRODUCT WAS RETURNED TO ASSIST IN OUR INVESTIGATION. HOWEVER, AN INTERNAL CLINICAL REVIEW WAS PERFORMED, SUGGESTING THAT THE EVENT WAS CAUSED BY ADVERSE PATIENT ANATOMY. PER OUR IFU AND THE COOK ZENITH PHYSICIAN REFERENCE MANUAL, IT IS STATED: "ALWAYS USE FLUOROSCOPY FOR GUIDANCE, DELIVERY AND OBSERVATION OF ANY ZENITH AAA ENDOVASCULAR GRAFT COMPONENTS WITHIN THE VASCULATURE." IT ALSO STATES, "THE OUTCOME OF AAA REPAIR UTILIZING AN ENDOVASCULAR GRAFT IS DEPENDENT UPON ACCURATE PRE-PROCEDURE MEASUREMENTS AND KNOWLEDGE OF THE PATIENT'S ANATOMY. GOOD ANGIOGRAPHY AND CT IMAGING ARE PARAMOUNT FOR ACCURATE PLANNING. CAREFUL EVALUATION OF THE PATIENT'S ANATOMY FROM THE DISTAL THORACIC AORTA TO THE SUPERFICIAL FEMORAL ARTERIES SHOULD BE MADE."

    Description of Event or Problem · 1

    DURING A STENT IMPLANT PROCEDURE, ONE OF THE BARBS ON THE DEVICE PUNCTURED THE AORTA WALL, CAUSING BLEEDING. PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA MAIN BODY GRAFT ENDOVASCULAR GRAFT MIH COOK, INC. NA F1920278X

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death