BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 5525645 · Received March 25, 2016

    Report

    Report Number
    3001845648-2016-00075
    Event Type
    Malfunction
    Date Received
    March 25, 2016
    Date of Event
    February 24, 2016
    Report Date
    April 6, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PMA/510(K)# OF SIMILAR DEVICE: K121430. IN RELATION TO THIS COMPLAINT ~ AS PER INFORMATION PROVIDED, THE CUSTOMER WAS NOT AWARE AT THE TIME OF THE PROCEDURE THAT THE PIECE OF THE DEVICE (TIP) HAD BECOME DETACHED FROM THE EVOLUTION DEVICE. THE PROCEDURE AT THE TIME WENT WELL AND THE STENT DEPLOYED AS NORMAL AND THEY WERE NOT AWARE THAT PART OF THE DEVICE WAS LEFT IN THE SCOPE. IT HAS BEEN INDICATED THAT THE PIECE OF THE DEVICE (TIP) IS BEING RETURNED FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED TO DATE. THEREFORE, WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT COULD BE CONFIRMED BASED ON CUSTOMER TESTIMONY. LIMITED INFORMATION HAS BEEN PROVIDED, THEREFORE A DEFINITIVE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-4-B DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-FC-10-11-4-B OF LOT C1181452 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. AS PER THE INSTRUCTIONS FOR USE, IFU0062-4, NOTES SECTION THE USER IS INSTRUCTED OF THE FOLLOWING: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". 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 POTENTIAL EMERGING TRENDS.

    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 MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PMA/510(K)# OF SIMILAR DEVICE: K121430. ONLY A PORTION OF THE DEVICE WAS RETURNED FOR EVALUATION. UPON EVALUATION IT WAS OBSERVED THAT THE FLEXOR WAS BROKEN AT THE DISTAL END OF THE ZIP PORT TUBE AND JUST PROXIMAL TO THE END OF THE COIL AT THE DISTAL FLEXOR. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE INFORMATION PROVIDED AND THE RETURNED PIECE OF BROKEN FLEXOR. A DEFINITIVE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED, AS ONLY A PIECE OF THE DEVICE WAS RETURNED FOR EVALUATION. PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-4-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 (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-FC-10-11-4-B OF LOT C1181452 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. AS PER THE INSTRUCTIONS FOR USE NOTES SECTION, THE USER IS INSTRUCTED OF THE FOLLOWING: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". 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 POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE PROCEDURE WENT WELL AND THE EVOLUTION BILIARY STENT DEPLOYED AS NORMAL AND CUSTOMERS WERE NOT AWARE THAT PART OF THE DEVICE WAS LEFT IN THE SCOPE. TWO DAYS POST PROCEDURE A PART OF THE COMPLAINT DEVICE FELL INTO A DIFFERENT PATIENT FROM THE ENDOSCOPE AND HAD TO BE RETRIEVED FROM THIS PATIENT. NOTE THIS REPORT RELATES TO THE DETACHMENT OF A PIECE OF THE EVOLUTION DEVICE DURING THE INITIAL PROCEDURE. A SEPARATE REPORT WAS SUBMITTED FOR PATIENT # 2. REFERENCE REPORT 3001845648-2016-00074. THE PIECE OF THE EVOLUTION DEVICE THAT DETACHED IN THE ENDOSCOPE IS PRESUMED AT THIS POINT TO BE THE TIP OF THE INTRODUCING CATHETER. EVENT MEETS REPORTING CRITERIA BASED ON THE MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY FOR 'TIP DETACHMENT'.

    Description of Event or Problem · 1

    FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT. ADDITIONAL INFORMATION WAS ALSO RECEIVED ON THE 13 MARCH 16 IN RELATION TO THIS EVENT AS FOLLOWS: ADDITIONAL INFORMATION WAS RECEIVED ON 13 MARCH 2016: "THE PIECE OF THE EVOLUTION BILIARY STENT DID NOT FALL INTO PATIENT. THE DOCTOR WAS TRYING TO PASS AN OLYMPUS BRAND TOME DOWN THE DUODENOSCOPE AND WAS HAVING A LOT OF DIFFICULTY, WHEN THEY PULLED THE TOME OUT THE PIECE OF THE EVOLUTION STENT CAME OUT THE BIOPSY PORT, NOT INTO THE PATIENT. THE NORMAL CLEAN OF THE SCOPE WAS DONE PRIOR, BRUSHING ETC AND THEY CHECKED WITH THEIR CLEANING PROTOCOL AND WHO WAS ON THAT SHIFT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182032 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD 10827002231334

    Patients

    Seq Age Sex Outcome Treatment
    1