BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 10975064 · Received December 9, 2020

    Report

    Report Number
    3001845648-2020-00923
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 10, 2020
    Report Date
    February 15, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON NAME: FGE METAL BILIARY CATHETER 510K: K121430 DEVICE EVALUATION: THE EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1759209 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON THE 20TH NOV 2020. THE RETURNED DEVICE LAB FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH THE ATTACHED FILES. IN SUMMARY THE FOLLOWING RESULTS WERE OBSERVED IN THE LAB EVALUATION: FLEXOR WAS OBSERVED BROKEN AT THE CLEAR SECTION. HANDLE WAS ACTUATING FINE BUT UNABLE TO FULLY DEPLOY THE STENT DUE TO FLEXOR BREAKAGE. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION ALL EVO-FC-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. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1759209 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT #C1759209; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT #C1759209 THE INSTRUCTIONS FOR USE IFU0062-5 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. FROM ADDITIONAL INFORMATION PROVIDED THE PRODUCT WAS NOT INSPECTED FOR KINKS OR DAMAGE BEFORE USE. A NOTIFICATION WAS SENT TO THE PRODUCT MANAGER TO CONSIDER RETRAINING AT THE FACILITY . ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE TORTUROUS PATH. IT IS POSSIBLE THAT DURING DEPLOYMENT TORTUOUS PATH MAY HAVE CAUSED A BUILD-UP OF PRESSURE RESULTING IN THE FLEXOR BREAK. ADDITIONALLY IT IS ALSO POSSIBLE THAT THE ROOT CAUSE COULD BE ATTRIBUTED TO DEVICE HANDLING. FROM ADDITIONAL INFORMATION PROVIDED THE PRODUCT WAS NOT INSPECTED FOR KINKS OR DAMAGE BEFORE USE. IT IS POSSIBLE THAT THE FLEXOR GOT DAMAGED ON HANDLING/REMOVAL OF THE DEVICE FROM THE PACKAGING BEFORE USE. SUMMARY: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    DR (B)(6) WAS INSERTING THE STENT INTO THE PATIENT THROUGH THE SCOPE, THE CATHETER WAS KINKED AND THE STENT COULDN'T GET OUT OF THE SHEATH. DEVICE EVALUATED 20-NOV-2020: FLEXOR (CLEAR SECTION) BROKEN.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K093619. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    DR (B)(6) WAS INSERTING THE STENT INTO THE PATIENT THROUGH THE SCOPE, THE CATHETER WAS KINKED AND THE STENT COULDN'T GET OUT OF THE SHEATH. DEVICE EVALUATED 20-NOV-2020: FLEXOR (CLEAR SECTION) BROKEN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR?(WHEN UNPACKING OR PREPARING THE EVOLUTION, WHILE INSERTING THE EVOLUTION IN THE PATIENT, DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCER, OR DURING STENT REPOSITIONING/REMOVAL) WHILE INSERTING THE EVOLUTION INTO THE PATIENT. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS DUODENOSCOPE - 2.8MM. WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? OPEN. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? AWG2-35-260 . DID ANY PART OF THE STENT CONTACT THE PATIENT'S ANATOMY WHEN THE COMPLAINT OCCURRED? YES. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? THE YELLOW MARKER SHOWING THE END OF THE STENT WAS ABOUT 1CM OUTSIDE THE PAPILLA. NONE. FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COMPLETE AND HOW OFTEN? NONE. IS THE PATIENT KNOWN TO BE COVID-19 POSITIVE? NO. STRICTURE INFORMATION: WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? WAS ABOUT 4CM, NOT SURE OF THE DIAMETER BUT THE STENT WAS ABLE TO GO THROUGH IT. WHERE WAS THE STRICTURE LOCATED IN THE BODY? IN THE PATIENTS COMMON BILE DUCT. WAS THERE RESISTANCE FELT PASSING WIRE GUIDE THROUGH STRICTURE? NO. WAS THERE RESISTANCE FELT PASSING THE EVOLUTION THROUGH STRICTURE? NO. WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? NO. QUESTIONS RELATED TO DURING INSERTION INTO PATIENT: WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? .NO WAS RESISTANCE FELT DURING INSERTION INTO PATIENT? IF YES, AT WHAT POINT? YES, WHEN DEPLOYING THE STENT. QUESTIONS RELATED TO DURING STENT PLACEMENT: DID THE PRODUCT FAIL DURING STENT DEPLOYMENT OR RECAPTURE?STENT DEPLOYMENT . WAS THE DIRECTIONAL BUTTON PRESSED DURING USE? YES IT WAS. WAS ANY PART OF THE STENT OBSERVED IN CONTACT WITH THE PATIENT'S ANATOMY AT THE TIME OF FAILURE? YES, THE STENT WAS IN THE COMMON BILE DUCT AND WE WERE GETTING READY TO DEPLOY IT. WAS THE YELLOW MARKER KEPT IN VIEW DURING DEPLOYMENT?YES IT WAS IN VIEW. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? THEY ARE WITH THE DR. QUESTIONS RELATED TO DURING INTRODUCER WITHDRAWAL: WAS FINAL STENT PLACEMENT CONFIRMED USING ENDOSCOPY / FLUOROSCOPY? IF YES, WHAT WAS USED? DID THE STENT OPEN SUFFICIENTLY TO ALLOW WITHDRAWAL OF INTRODUCER SAFELY? WAS THE SAFETY WIRE FULLY REMOVED BEFORE REMOVING THE DELIVERY SYSTEM? DID ANY PART OF THE PRODUCT SNAG/GET CAUGHT WITH THE STENT WHEN REMOVING THE DELIVERY SYSTEM? ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? QUESTIONS RELATED TO DURING STENT REPOSITIONING/REMOVAL: WHAT INSTRUMENT WAS USED FOR STENT REPOSITIONING / REMOVAL? FORCEPS, SNARE. WAS THE LASSO (SUTURE) LOOP USED DURING REPOSITIONING O INSTRUMENTS WERE USED. THE STENT FAILED TO DEPLOY/GET OUT OF THE SHEATH. IT WAS PULLED THROUGH THE SCOPE CHANNEL. THE SYSTEM WAS INSIDE THE PATIENT AND MADE CONTACT WITH THE PATIENT. THE STENT DIDN¿T GET OUT OF THE SHEATH. THE HOSPITAL WON¿T ALLOW US TO HAVE THE IMAGES BECAUSE THEY ARE CONFIDENTIAL AND THE PATIENT HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438415 EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD C1759209 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1