BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 5465949 · Received February 29, 2016

    Report

    Report Number
    3001845648-2016-00055
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    January 8, 2016
    Report Date
    February 1, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SPECIFIC EVOLUTION DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS/SETS (EVOLUTION) DEVICES CURRENTLY APPROVED/MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PMA/510(K)# OF SIMILAR DEVICE AS FOLLOWS: K121430. THE DELIVERY SYSTEM WAS RETURNED WITH THE STENT PARTIALLY DEPLOYED. THE CANNULA WAS EXPOSED OUT THROUGH THE LOCKWIRE ASSEMBLY. ON EVALUATION OF THE DEVICE IT WAS NOTED THAT THE GREEN LOCK WIRE WAS PROTRUDING OUT THROUGH THE CLEAR SECTION OF THE SHEATH. THE LOCK WIRE WAS PUT BACK IN THE LUMEN, AND THE HANDLE WAS ACTUATED AND THE STENT WAS MANUALLY DEPLOYED. THERE WAS NO ISSUE NOTED WITH THE STENT. THE DEVICE WAS EXAMINED UNDER THE MICROSCOPE AND IT WAS VISIBLE THAT THE LOCK WIRE LUMEN IN THE YELLOW MARKER WAS TORN ALONG ITS LENGTH, INDICATING THAT THE LOCK WIRE PROTRUDED DISTAL TO THE YELLOW MARKER BEFORE IT HAD PIERCED OUT THROUGH THE DISTAL FLEXOR. UNFORTUNATELY, THERE WAS NO WAY TO MEASURE THE LOCK WIRE ACCURATELY DUE TO THE DAMAGE AT THE FLLA SOCKET. AS ACTUAL USE CONDITIONS CANNOT BE REPLICATED IN THE LABORATORY WE ARE UNABLE TO CONCLUSIVELY DETERMINE HOW THE DAMAGE WAS CAUSED. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FLEXOR SHEATH WAS NOTED TO BE DAMAGED WITH THE GREEN LOCK WIRE PROTRUDING THROUGH THE SHEATH AND THE STENT COULD NOT BE DEPLOYED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1162388 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION, ALL EVO-10-11-6-B DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE INSTRUCTS THE USER TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". FROM THE INFORMATION PROVIDED THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Description of Event or Problem · 1

    THE ATTENDING NURSE EXPLAINED SHE WAS ATTEMPTING TO DEPLOY THE EVOLUTION BILIARY STENT IN THE CBD OF THE PATIENT. THE NURSE SQUEEZED THE TRIGGER OF THE HANDLE BUT THE STENT WAS NOT REALLY DEPLOYING. THE WHOLE SYSTEM WAS PULLED OUT OF THE BILE DUCT. THE STENT WAS PARTIALLY DEPLOYED WHEN REMOVING FROM THE PATIENT. EVENT MEETS REPORTING CRITERIA BASED ON THE MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY FOR A DEPLOYMENT ISSUE RESULTING IN THE EXPOSED STENT BEING REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122514 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1