BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 5519398 · Received March 23, 2016

    Report

    Report Number
    3001845648-2016-00074
    Event Type
    Injury
    Date Received
    March 23, 2016
    Date of Event
    February 26, 2016
    Report Date
    April 13, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231334
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    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/5109K)# OF SIMILAR DEVICE: K121430. THE USER WAS NOT AWARE AT THE TIME OF THE INITIAL PROCEDURE THAT THE PIECE OF THE DEVICE (TIP) HAD BECOME DETACHED FROM THE EVOLUTION DEVICE. THE INITIAL 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. ADDITIONAL QUERIES HAVE BEEN SENT IN RELATION TO THE TYPE OF PROCEDURE THAT WAS BEING PERFORMED, THE DEVICE THAT WAS BEING USED IN THE PROCEDURE WHEN THE OTHER PIECE OF THE DEVICE (TIP) FELL INTO THE PATIENT, DETAILS IN RELATION TO THE CLEANING THAT WAS COMPLETED ON THE SCOPE, AND THE OUTCOME OF THE PATIENT. A RESPONSE HAS NOT BEEN RECEIVED TO DATE. THERE IS NO DEVICE BEING RETURNED FOR EVALUATION FOR THIS COMPLAINT. 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 EVOLUTION DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT (B)(4). THE DEVICE THAT WAS USED IN THIS PROCEDURE IS UNKNOWN AND A QUERY HAS BEEN SENT TO CONFIRM THE DEVICE. THE PIECE WAS PULLED OUT THROUGH THE BIOPSY CHANNEL. FROM THE INFORMATION PROVIDED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE INSTRUCTIONS FOR USE FOR EVOLUTION BILIARY STENT SYSTEM ¿ FULLY COVERED ADVISES THE USER OF THE FOLLOWING ¿UPON COMPLETION OF PROCEDURE, DISPOSE OF DEVICE PER INSTITUTIONAL GUIDELINES FOR BIOHAZARDOUS MEDICAL WASTE.¿ 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/5109K)# OF SIMILAR DEVICE: K121430. THIS PR INVESTIGATES THE SECOND EVENT WHERE THE PIECE OF EVOLUTION DEVICE REMAINED IN THE SCOPE FROM A PREVIOUS PROCEDURE. REFERENCE ALSO REPORT # 3001845648-2016-00075 AS PER REPORT 3001845648-2016-00075, THEY WERE 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. ADDITIONAL QUERIES WERE SENT AND THE FOLLOWING RESPONSE WAS RECEIVED ON (B)(6) 2016 "NO THERE ARE NO IMAGES. THE PROCEDURE WAS AN ERCP AND WHEN I SPOKE WITH CUSTOMER AGAIN THE TIP PIECE OF THE EVOLUTION BILIARY STENT DID NOT FALL INTO PATIENT. THE DR 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. THE PIECE OF THE DEVICE (TIP) WAS RETURNED AS PER REPORT # 3001845648-2016-00075. THERE IS NO DEVICE BEING RETURNED FOR EVALUATION FOR THIS COMPLAINT. THEREFORE, WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT COULD BE CONFIRMED BASED ON CUSTOMER TESTIMONY. LIMITED INFORMATION WAS PROVIDED, THEREFORE A DEFINITIVE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. ADDITIONAL INFORMATION WAS RECEIVED WHICH CONFIRMED THAT THE SCOPE HAD BEEN CLEANED. 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 CIRL. 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. THE PIECE WAS PULLED OUT THROUGH THE BIOPSY CHANNEL. FROM THE INFORMATION PROVIDED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE INSTRUCTIONS FOR USE FOR EVOLUTION BILIARY STENT SYSTEM ¿ FULLY COVERED ADVISES THE USER OF THE FOLLOWING ¿UPON COMPLETION OF PROCEDURE, DISPOSE OF DEVICE PER INSTITUTIONAL GUIDELINES FOR BIOHAZARDOUS MEDICAL WASTE.¿ COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    A PIECE OF THE EVOLUTION BILIARY STENT CATHETER FROM AN EARLIER PROCEDURE HAD COME AWAY AND GOT LODGED IN THE SCOPE. THE USER FACILITY ONLY BECAME AWARE OF THIS WHEN THE SCOPE WAS USED WITH A DIFFERENT PATIENT AND IT FELL OUT INTO THE PATIENT. THE PHYSICIAN WAS TRYING TO ADVANCE A TRU-TOME DOWN THE DUODENOSCOPE AND COULDN'T, HE PULLED THE DEVICE OUT OF THE BIOPSY PORT AND A PIECE OF A PLASTIC CATHETER FROM AN EVOLUTION STENT CAME OUT. THE PIECE OF THE EVOLUTION DEVICE HAS BEEN RETRIEVED FROM THIS PATIENT. AS PER THE USER FACILITY THE DUODENOSCOPE HAD BEEN CLEANED FOLLOWING THE INITIAL PROCEDURE.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF ADDITIONAL INFORMATION AS FOLLOWS: "THE PIECE OF THE EVOLUTION BILIARY STENT DID NOT FALL INTO THE 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." INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: A PIECE OF THE EVOLUTION BILIARY STENT CATHETER FROM AN EARLIER PROCEDURE HAD COME AWAY AND GOT LODGED IN THE SCOPE. THE USER FACILITY ONLY BECAME AWARE OF THIS WHEN THE SCOPE WAS USED WITH A DIFFERENT PATIENT AND IT FELL OUT INTO THE PATIENT. THE PHYSICIAN WAS TRYING TO ADVANCE A TRU-TOME DOWN THE DUODENOSCOPE AND COULDN'T, HE PULLED THE DEVICE OUT OF THE BIOPSY PORT AND A PIECE OF A PLASTIC CATHETER FROM AN EVOLUTION STENT CAME OUT. THE PIECE OF THE EVOLUTION DEVICE HAS BEEN RETRIEVED FROM THIS PATIENT. AS PER THE USER FACILITY THE DUODENOSCOPE HAD BEEN CLEANED FOLLOWING THE INITIAL PROCEDURE. THIS PR INVESTIGATES THE SECOND EVENT WHERE THE PIECE OF EVOLUTION DEVICE REMAINED IN THE SCOPE FROM A PREVIOUS PROCEDURE. REFERENCE ALSO REPORT # 3001845648-2016-00075.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174850 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD 10827002231334

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention