BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 3965816 · Received June 26, 2014

    Report

    Report Number
    3001845648-2014-00110
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 27, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS COMPLAINT IS AN EVOLUTION BILIARY STENT SYSTEM - FULLY COVERED DEVICE. THIS SPECIFIC DEVICE IS NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS DEEMED SIMILAR TO OTHER EVOLUTION BILIARY STENT PART NUMBERS (UNCOVERED) WHICH ARE CURRENTLY MARKETABLE IN THE US. SIMILAR DEVICE DETAILS AS FOLLOWS: EVO-8-9-X-B, EVO-10-11-X-B WHERE X = 4,6, 8 OR 10; COMMON DEVICE NAME FGE CATHETER, BILIARY DIAGNOSTIC; K121430. THIS COMPLAINT REPORT MEETS THE REQUIREMENT OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE FOR THIS PRODUCT FAMILY FOR COMPLAINT REPORTS OF 'PAST POINT OF NO RETURN - PERMANENT STENT REMOVED FROM PT INCLUDING PARTIALLY DEPLOYED STENTS.' THERE WERE NO EVO-FC-10-11-6-B DEVICES OF LOT NUMBER C974130 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. ONE X EVO-FC-10-11-6-B OF LOT NUMBER C974130 WAS RETURNED FOR EVAL. THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGE AND WAS OPEN ON RECEIPT. ON RETURN OF THE DEVICE, IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED FROM THE SHEATH. THE STENT WAS DEPLOYED IN THE LABORATORY WITH NO ISSUES. THERE WAS NO DAMAGE NOTED TO THE DEVICE OR THE STENT. THE HANDLE FUNCTIONED CORRECTLY AND THE INNER CATHETER MOVED FREELY WITHIN THE FLEXOR SHEATH. THERE WERE NO MANUFACTURING ISSUES NOTED ON THE DEVICE. IT WAS NOTED THAT THE STENT WAS DISENGAGED FROM THE INTRODUCER. THIS WOULD HAVE OCCURRED IF THE SAFETY WIRE (LOCK WIRE) HAD BEEN DISENGAGED AT SOME TIME AND PULLED BACK. WHEN THE DEICE IS MANUFACTURED CORRECTLY AS THIS UNIT WAS IT IS NOT POSSIBLE FOR THE STENT TO DISENGAGE WITHOUT THE SAFETY WIRE (LOCK WIRE) BEING DISENGAGED AND PULLED BACK. THE SAFETY WIRE (LOCK WIRE) WAS RETURNED IN THE DEVICE AND THE SAFETY WIRE (LOCK WIRE) HOUSING WAS ENGAGED. THE DISTAL END OF THE SAFETY WIRE (LOCK WIRE) WAS NOT ENGAGED CORRECTLY WITH THE RETAINING SUTURE OR THE STENT GRASPING FEATURE, NOR WAS IT WITHIN THE LUMEN OF THE YELLOW ENDOSCOPIC MARKER. IT IS NOT POSSIBLE TO MANUFACTURE THE DEVICE WITHOUT THE DISTAL END OF THE SAFETY WIRE (LOCK WIRE) CORRECTLY ENGAGED AS THE STENT HAS TO BE LOCKED CORRECTLY ONTO THE INTRODUCER IN ORDER TO LOAD IT INTO THE FLEXOR SHEATH. THEREFORE THE SAFETY WIRE (LOCK WIRE) MUST HAVE BEEN PULLED BACK TO UNLOCK THE STENT AND THEN PUSHED FORWARD INTO THE POSITION IN WHICH IT WAS FOUND WHEN RETURNED. HOWEVER, AS ACTUAL USE CONDITIONS COULD NOT BE REPLICATED IN THE LABORATORY WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE OF THE ISSUE THAT THE USER HAD. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AS THE STENT DEPLOYED WITH NO ISSUES. CLARIFICATION ON RECEIVED INFO HAS BEEN REQUESTED AS TO WHETHER THE USER ATTEMPTED TO RECAPTURE THE STENT AND CONFIRMATION AS TO WHETHER THE SAFETY WIRE (LOCK WIRE) WAS ATTEMPTED TO BE REMOVED AT ANY TIME DURING THE PROCEDURE. A RESPONSE HAS NOT YET BEEN RECEIVED. AS PER THE INSTRUCTIONS FOR USE, IFU, STEP 11 ADVISES THE USER OF THE FOLLOWING: "WHEN STENT POINT OF NO RETURN HAS BEEN PASSED DISCONNECT THE LUER LOCK FITTING TO REMOVE SAFETY WIRE COMPLETELY FROM DELIVERY HANDLE. STEP 12 CONTINUE DEPLOYING STENT BY SQUEEZING TRIGGER." PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-6-B DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE IS A SPECIFIC PRODUCTION INSTRUCTION TO DEPLOY THE STENT 50% AND RESHEATH IT TO ENSURE THAT IT FUNCTIONS CORRECTLY. THERE IS ALSO A SPECIFIC FQC INSPECTION OF THE FINISHED PRODUCT TO CHECK THAT SAFETY WIRE (GREEN ANCHOR WIRE) IS INSERTED INTO THE YELLOW MARKER LUMEN USING A MICROSCOPE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE EVO-FC-10-11-6-B DEVICE OF LOT NUMBER (B)(4) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. FROM THE INFO PROVIDED THERE WERE NO ADVERSE EFFECTS TO THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS. (B)(4)

    Description of Event or Problem · 1

    WHEN THE STENT WAS BEING PLACED IT DID NOT OPEN PROPERLY SO THEY COULD NOT KEEP GOING. THE STENT COULD NOT BE FULLY IMPLANTED. THIS DID NOT IMPACT ON THE PT. A NEW STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. ADD' INFO WAS RECEIVED INDICATING THE USER EXPERIENCED DIFFICULTY DURING DEPLOYMENT WHICH RESULTED IN REMOVING THE STENT UNSHEATHED FROM THE PT. IT WAS FURTHER CONFIRMED BY THE USER THAT THE STENT HAD MADE CONTACT WITH THE PT. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373852 EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED NONE MQR COOK IRELAND LTD C974130

    Patients

    Seq Age Sex Outcome Treatment
    1