BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1766582 · Received July 19, 2010

    Report

    Report Number
    1820334-2010-00329
    Event Type
    Death
    Date Received
    July 19, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 21, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CONVERSION TO OPEN SURGICAL REPAIR AND DEATH ARE LABELED IN THE IFU. DIFFICULTY REMOVING TOP CAP IS LABELED IN THE TROUBLE-SHOOTING PORTION OF THE PHYSICIAN REFERENCE MANUAL. THIS PRODUCT LINE HAS ADDRESSED ALL DESIGN CONTROL REQUIREMENTS AND SHOWN THE DEVICE HAS MET THE PREDETERMINED REQUIREMENTS AND THAT THOSE REQUIREMENTS MEET THE NEEDS OF THE END USER. EACH DEVICE IS SENT WITH AN IFU, WHICH DESCRIBES THE INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, AND THE PROPER DEPLOYMENT SEQUENCE. SPECIFIC TO THIS CASE THE INSTRUCTIONS FOR USE FOR THE MAIN BODY GRAFT STATES: "READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW THE INSTRUCTIONS, WARNINGS AND PRECAUTIONS MAY LEAD TO SERIOUS CONSEQUENCES OR INJURY TO THE PATIENT." SPECIFICALLY, THE IFU LISTS KEY ANATOMIC CRITERIA THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING. ALL TRAINED PHYSICIANS HAVE ACCESS TO PHYSICIANS REFERENCE MANUAL THAT LISTS TROUBLESHOOTING TECHNIQUES IF THIS FAILURE MODE IS TO OCCUR. CONTROLS ARE IN PLACE FOR THE SOLDERING PROCESS ENSURING THE BARBS, ON THE SUPRARENAL STENT, HAVE THE CORRECT AMOUNT OF SOLDER AND CORRECT AMOUNT OF SPACING BETWEEN THE STENT STRUTS AND BARB WIRE. THE RETURNED DEVICE WAS EXAMINED BY INTERNAL PERSONNEL. THE FOLLOWING WAS NOTED DURING THE COURSE OF THE INVESTIGATION: THE SOLDER QUANTITY ON THE SUPRARENAL STENT APPEARED TO BE WITHIN TOLERANCE. SCRATCHES WERE NOTED ON THE TOP STENT. AN INDENTATION IN THE PROXIMAL CANNULA SOLDER OF THE SUPRARENAL STENT WAS NOTED. THE PROXIMAL CANNULA SOLDER OF THE SUPRARENAL STENT MEASURED 0.042" IN DIAMETER. THE DISTAL CANNULA SOLDER OF THE SUPRARENAL STENT MEASURED 0.044" IN DIAMETER. SCRATCHES WERE NOTED ON THE INSIDE OF THE TOP CAP. THE STENT GRAFT APPEARED TO BE CLEANED AND SCRUBBED PRIOR TO BEING RETURNED TO COOK INC. THE GRAFT MATERIAL APPEARED TO HAVE BEEN WORN OR "FUZZY" FROM WHOM EVER CLEANED IT. VERY LITTLE STAINING OR BLOOD WAS FOUND ON THE GRAFT UPON RETURN TO COOK INC. ONE OF THE BARBS ON THE SUPRARENAL STENT, CONTAINED A BEND OR KINK IN THE BARB. MULTIPLE ATTEMPTS WERE MADE TO REQUEST COPIES IMAGING OF THE PATIENT'S ANATOMY; HOWEVER, THEY WERE UNSUCCESSFUL. A DEFINITIVE ROOT CAUSE CAN NOT BE IDENTIFIED OR DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    AFTER DEPLOYMENT OF THE STENT, THE CAP CONTAINING THE STENT WAS UNABLE TO BE RELEASED CORRECTLY. DURING THE MANEUVER TO RELEASE IT, THE WHOLE STENT TOOK A DIFFERENT POSITION CAUSING PROBLEMS IN THE AORTIC ARTERY. SO THE SURGEON WAS OBLIGED TO REMOVE THE STENT BY CONVERSION TO OPEN SURGICAL REPAIR. THE PATIENT EXPIRED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2010: "THE PATIENT HAD A HIGH RISK ASSOCIATED WITH AN OPEN SURGICAL REPAIR OF THE ABDOMINAL AORTIC ANEURYSM." AND "THE PATIENT DEATH OCCURRED AFTER THE OPEN SURGICAL REPAIR OF THE ABDOMINAL AORTIC ANEURYSM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2473920

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death