BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 5213111 · Received November 10, 2015

    Report

    Report Number
    3001845648-2015-00225
    Event Type
    Injury
    Date Received
    November 10, 2015
    Date of Event
    September 17, 2015
    Report Date
    October 13, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO ANOTHER METAL BILIARY STENT/SET (EVOLUTION) DEVICE CURRENTLY MARKETED IN THE US. A SIMILAR METAL STENT/SET (EVOLUTION) DEVICE IS CURRENTLY MARKETED IN THE US UNDER THE FOLLOWING 510 (K) #: K121430. UPON EVALUATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE LOCKWIRE AND THE STENT WERE NOT RETURNED TO CIRL. ALL OTHER PIECES OF THE DEVICE WERE PRESENT. THE CIRL RESEARCH & DEVELOPMENT ENGINEER EXAMINED THE DEVICE UNDER THE MICROSCOPE AND DISCOVERED THAT THE JOINT BETWEEN THE RETRIEVAL LOOP SHAFT AND THE RETRIEVAL LOOP PUSHER WAS SOLDERED BUT IT WAS BROKEN COMPLETELY AND THE RETRIEVAL LOOP CANNULA HAD PIERCED OUT THROUGH THE SIDE OF THE FLEXOR. THE RETRIEVAL LOOP WIRE TO THE RETRIEVAL LOOP PUSHER BROKE ON ONE SIDE ALSO. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE JOINT BETWEEN THE RETRIEVAL LOOP SHAFT AND THE RETRIEVAL LOOP PUSHER WAS FOUND TO BE BROKEN COMPLETELY AND RETRIEVAL LOOP CANNULA HAD PIERCED OUT THROUGH THE SIDE OF THE FLEXOR. AS THE JOINT BETWEEN THE RETRIEVAL LOOP SHAFT AND THE RETRIEVAL LOOP PUSHER WAS BROKEN THIS WOULD ALLOW THE STENT CARRIER TO DETACH AND BE LEFT IN THE PATIENT REQUIRING ITS LATER REMOVAL AS DETAILED IN THE COMPLAINT. THE EXACT PATIENT ANATOMY, THE EXACT SCOPE POSITION AND THE EXACT SEQUENCE OF HOW THE DEVICE WAS USED IN PROCEDURE CANNOT BE ASCERTAINED, SO IT IS NOT POSSIBLE TO REPLICATE THE FAILURE. THEREFORE IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE FAILURE I.E. WHAT CAUSED THE STENT CARRIER TO RETRIEVAL LOOP SHAFT JOINT TO BREAK LEADING THE RETRIEVAL LOOP PIERCING THE FLEXOR AND THE STENT CARRIER DETACHING. IT IS THOUGHT THAT THE FAILURE OF THE JOINT BETWEEN THE RETRIEVAL LOOP SHAFT AND THE RETRIEVAL LOOP PUSHER IS UNLIKELY TO BE THE RESULT OF A MANUFACTURING DEFECT AS THIS JOINT IS PROOF LOADED TO 40N BY THE RETRIEVAL LOOP ASSEMBLY SUPPLIER DURING ITS ASSEMBLY. ALSO THE STENT CARRIER TO RETRIEVAL LOOP SHAFT ASSEMBLY (WHICH THE RETRIEVAL LOOP SHAFT AND THE RETRIEVAL LOOP JOINT IS PART OF) IS PROOF LOADED TO 15N DURING THE INTRODUCER MANUFACTURE IN COOK (B)(4). PRIOR TO DISTRIBUTION ALL EVO-FC-8-9-6-B DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR THE EVO-FC-8-9-6-B DEVICE OF LOT NUMBER C1060350 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. FROM THE INFORMATION PROVIDED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO ANOTHER METAL BILIARY STENT/SET (EVOLUTION) DEVICE CURRENTLY MARKETED IN THE US. A SIMILAR METAL STENT/SET (EVOLUTION) DEVICE IS CURRENTLY MARKETED IN THE US UNDER THE FOLLOWING 510 (K) #: K121430. UPON EVALUATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE LOCKWIRE AND THE STENT WERE NOT RETURNED TO CIRL. ALL OTHER PIECES OF THE DEVICE WERE PRESENT. THE JOINT BETWEEN THE RETRIEVAL LOOP SHAFT AND THE RETRIEVAL LOOP PUSHER WAS SOLDERED BUT IT WAS BROKEN COMPLETELY AND IT HAD PIERCED OUT THROUGH THE SIDE OF THE FLEXOR. THE RETRIEVAL LOOP WIRE TO THE RETRIEVAL LOOP PUSHER BROKE ON ONE SIDE. IT IS POSSIBLE THAT UPON DEPLOYMENT OF THE STENT AND REMOVAL OF THE LOCKWIRE, THE USER MAY HAVE CONTINUED TO ACTUATE THE HANDLE, HOWEVER THE SHEATH WAS NOT RETRACTED AT THE SAME TIME. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE JOINT BETWEEN THE RETRIEVAL LOOP SHAFT AND THE RETRIEVAL LOOP PUSHER WAS BROKEN COMPLETELY AND IT HAD PIERCED OUT THROUGH THE SIDE OF THE FLEXOR. PRIOR TO DISTRIBUTION ALL EVO-FC-8-9-6-B DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR THE EVO-FC-8-9-6-B DEVICE OF LOT NUMBER C1060350 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. FROM THE INFORMATION PROVIDED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO AN UPDATE TO THE INVESTIGATION CONCLUSION OF THIS EVENT. THE FOLLOWING CONCLUSION WAS ADDED TO THE INVESTIGATION OF THIS DEVICE: "AS THE JOINT BETWEEN THE RETRIEVAL LOOP SHAFT AND THE RETRIEVAL LOOP PUSHER WAS BROKEN THIS WOULD ALLOW THE STENT CARRIER TO DETACH AND BE LEFT IN THE PATIENT REQUIRING ITS LATER REMOVAL AS DETAILED IN THE COMPLAINT. THE EXACT PATIENT ANATOMY, THE EXACT SCOPE POSITION AND THE EXACT SEQUENCE OF HOW THE DEVICE WAS USED IN PROCEDURE CANNOT BE ASCERTAINED, SO IT IS NOT POSSIBLE TO REPLICATE THE FAILURE. THEREFORE IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE FAILURE I.E. WHAT CAUSED THE STENT CARRIER TO RETRIEVAL LOOP SHAFT JOINT TO BREAK LEADING THE RETRIEVAL LOOP PIERCING THE FLEXOR AND THE STENT CARRIER DETACHING. IT IS THOUGHT THAT THE FAILURE OF THE JOINT BETWEEN THE RETRIEVAL LOOP SHAFT AND THE RETRIEVAL LOOP PUSHER IS UNLIKELY TO BE THE RESULT OF A MANUFACTURING DEFECT AS THIS JOINT IS PROOF LOADED TO 40N BY THE RETRIEVAL LOOP ASSEMBLY SUPPLIER DURING ITS ASSEMBLY. ALSO THE STENT CARRIER TO RETRIEVAL LOOP SHAFT ASSEMBLY (WHICH THE RETRIEVAL LOOP SHAFT AND THE RETRIEVAL LOOP JOINT IS PART OF) IS PROOF LOADED TO 15N DURING THE INTRODUCER MANUFACTURE IN COOK (B)(4)."

    Description of Event or Problem · 1

    THE INITIAL INFORMATION RECEIVED INDICATED THE USER HAD DIFFICULTY RELEASING THE EVOLUTION BILIARY FULLY COVERED STENT. THE USER REPORTED THE INTRODUCER WAS PIERCED/DAMAGED. ADDITIONAL INFORMATION RECEIVED ON THE 13 OCT 2015 CONFIRMED THE USER HAD RELEASED THE STENT WITH A LOT OF FRICTION. AFTER THAT THEY TRIED TO PULL THE DELIVERY SYSTEM BACK INTO THE WORKING CHANNEL. THIS IS WHEN THE SHEATH OF THE DELIVERY SYSTEM BECAME PIERCED/DAMAGED AND A PART OF THE DELIVERY SYSTEM FELL OFF. THE USER RETRIEVED IT WITH A FORCEPS/SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746028 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1