EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
Report
- Report Number
- 3001845648-2018-00291
- Event Type
- Death
- Date Received
- June 26, 2018
- Date of Event
- May 29, 2018
- Report Date
- February 1, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002231341
- PMA / PMN Number
- K121430
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031 INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031 INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510(K) NUMBER: K121430. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. . IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510(K) NUMBER: K121430 COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. DEVICE EVALUATION: THE EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1435219 WAS RETURNED TO CIRL AND EVALUATED ON 04 JULY 2018. HOWEVER, THE STENT OF THIS DEVICE WAS NOT RETURNED AS IT REMAINED IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED: 1. WHAT OTHER DEVICES WERE USED (USING SAME WIRE GUIDE), IN ADVANCE OF USING THE COOK IRL DEVICE? THE BOSTON TRAPEZOID BASKET 2. CAN THEY DESCRIBE FULLY THE PROCEDURE(S) DONE ON THE PATIENT (FROM START TO FINISH) I.E. WAS A SPHINCTEROTOMY PERFORMED, WERE THERE STONES REMOVED OR LITHOTRIPSY ETC? (NEW QUESTION ADDED POST LAB). COOK ZIMMON DOUBLE PIGTAIL STENT REMOVED INITIALLY USING A SNARE, TRAPEZOID EXTRACTION BASKET USED TO REMOVE POTENTIALLY A STONE OF SLUDGE 3. COULD THEY ESTIMATE HOW FAR BEYOND THE STRICTURE WAS THE WIREGUIDE FOLLOWING CANNULATION? UNKNOWN 4. WAS THE WIRE GUIDE ALWAYS VISIBLE EXITING BEYOND THE TIP OF THE DELIVERY SYSTEM OR DID THE WIRE GUIDE COME BACK WITHIN DELIVERY SYSTEM AT SOME POINT AND REQUIRE TO BE PUSHED FORWARD AGAIN? UNKNOWN- WOULD NEED TO CLARIFY WITH THE SURGEON 5. WAS THE WIRE GUIDE LOCKED ON A WIRE LOCK DURING DEPLOYMENT? NO WIRE LOCK USED 6. CAN THEY CONFIRM IF THE YELLOW MARKER WAS INSIDE OF THE DUCT WHEN THE STENT WAS BEING DEPLOYED? NEED TO CONFIRM 7. CAN THEY CONFIRM THAT THERE WAS NO ISSUE WITH STENT DEPLOYMENT? NO ISSUE WITH STENT DEPLOYMENT 8. WAS THE REMOVAL OF THE DEVICE ATTEMPTED WITH THE WIRE LOCKED IN A WIRE LOCK? NO 9. WAS THE DEVICE AND WIREGUIDE REMOVED FROM THE PATIENT THROUGH THE SCOPE CHANNEL OR WAS THE ENDOSCOPE REMOVED WITH THE DEVICE AND WIREGUIDE AS A SINGLE UNIT. THE DEVICE AND WIRE GUIDE WAS REMOVED THROUGH THE SCOPE CHANNEL 10. WHERE WAS THE BALLOON POSITIONED FOR MOVING THE STENT? I.E. DID THEY PLACE THE BALLOON THROUGH THE STENT AND EXPAND IT ON THE FAR SIDE FOLLOWED BY PULLING IT BACK OR DID THEY EXPAND THE BALLOON WITHIN THE STENT TO MOVE IT? THE BALLOON WAS EXPANDED WITHIN THE STENT TO REMOVE 11. DID THEY PERFORM AN AUTOPSY, WAS THE LOCATION OF THE BLEED FOUND AND IF SO WHERE WAS THE LOCATION OF THE BLEED/PERFORATION? I WILL NEED TO FOLLOW UP ON AUTOPSY RESULTS. DR DID MENTION INITIALLY THERE WAS BLOOD CLOTTING IN THE DUODENUM UPDATE RECEIVED 12 JUNE 2018: WCA PRODUCT MANAGER TELEPHONED WCA CUSTOMER RELATIONS TO REPORT THAT THE DR INFORMED COOK SBU THAT DAY THAT THE PATIENT HAD DIED DUE TO COMPLICATIONS OF BLEEDING (DATE OF PT DEATH NOT SUPPLIED; WCA PRODUCT MANAGER BELIEVES IT WAS AT LEAST 4 OR 5 DAYS AFTER THE COMPLAINT EVENT) THE DOCTOR INFORMED THE WCA PRODUCT MANAGER THAT HE BELIEVES THE DELIVERY SYSTEM AND/OR THE STENT CAUSED THE BLEEDING. T.G. 12 JUNE 2018 LAB EVALUATION: UPON EVALUATION OF THE RETURNED DEVICE, THE GUIDE WIRE APPEARED TO BE PROTRUDING FROM THE DEVICE. THERE WAS A KINK IN THE FLEXOR BUT THIS WAS BELIEVED TO BE NOT RELATED AS DEVICE WAS NOT RETURNED IN ORIGINAL PACKAGING. THE SPECIFIC LOCATION OF DEFECTS ON THE DEVICE: WIRE GUIDE WAS EXITING THROUGH POLYAMIDE TUBE DISTAL TO ENDOSCOPIC MARKER AND PROXIMAL TO FIRST MARKER. STENT WAS MISSING AS IT WAS DEPLOYED WITHIN PATIENT. IT APPEARED THAT THE WIRE GUIDE (WHICH WAS A COMPETITORS DEVICE) HAD EXITED AT LOCATION DESCRIBED IN COMPLAINT AND CAUSED JAMMING OF THE COOK IRELAND DEVICE. NOTHING WAS FOUND WRONG WITH COOK IRELAND DEVICE. IT APPEARED THAT COATING OF THE GUIDE WIRE SHEARED AND WIRE EXITED COOK IRELAND DEVICE. NOTE: RED TAB WAS FULLY BACK. THERE DIDN'T APPEAR TO BE AN ISSUE WITH DEPLOYMENT. NO DAMAGE TO LOCK WIRE. THE DEFECT WAS VISUALLY CONFIRMED, WIRE GUIDE HAD PERFORATED THROUGH COOK IRELAND DEVICE, WHICH LED TO JAMMING. FURTHER INVESTIGATION: FURTHER ENGINEERING INVESTIGATION AND TESTING CONCLUDED: THE PERFORATION OF THE POLYIMIDE TUBE CAN BE ATTRIBUTED TO THE FOLLOWING SEQUENCE OF EVENTS: (1) THE WIREGUIDE POSITION WAS LOST AT SOME POINT DURING THE PROCEDURE AND IT SLIPPED BACK TO A POSITION PROXIMAL TO THE YELLOW MARKER WITHIN THE DEVICE. AN ATTEMPT WAS MADE TO ADVANCE THE WIREGUIDE FOLLOWING THE LOSS OF WIREGUIDE POSITION. FROM THE COMPLAINT IT IS CLEAR THAT THE STENT WAS PLACED TOO FAR INTO THE DUCT AND REPOSITIONING WAS REQUIRED HENCE THE PHYSICIAN NEEDED TO KEEP THE DUCT CANNULATED TO ENABLE THE INTRODUCTION OF ANOTHER DEVICE FOR REPOSITIONING OF THE STENT FOLLOWING THE REMOVAL OF THE EVOLUTION BILIARY DEVICE. (2) THE OUTER COATING OF THE WIRE GUIDE WAS NOT PRESENT OVER THE WIREGUIDE TIP AS THE USER ATTEMPTED TO ADVANCE THE WIREGUIDE THROUGH THE DEVICE. (THE REASON FOR THE DAMAGED TIP IS UNKNOWN, HOWEVER IT MAY HAVE BEEN DAMAGED BY DEVICES USED EARLIER IN THE PROCEDURE (E.G. BOSTON TRAPEZOID RETRIEVAL BASKET AS OUTLINED IN THE COMPLAINT) AND CANNOT BE ATTRIBUTED TO A DEFECTIVE COOK DEVICE. (3) AS THE WIRE GUIDE WAS ADVANCED TO THE LOCATION OF THE KINK, THE UNPROTECTED BARE METAL TIP OF THE DEFECTIVE JAGWIRE WIREGUIDE SLICED THROUGH THE POLYAMIDE. AS PER THE INSTRUCTIONS FOR USE, STATES: "REMOVE STENT DELIVERY SYSTEM FROM PACKAGE AND BACKLOAD DEVICE OVER A PREPOSITIONED WIRE GUIDE, ENSURING THAT THE WIRE GUIDE EXITS CATHETER AT ZIP PORT". DIAGRAMS INDICATE AND INSTRUCT THE USER HOW TO USE GUIDE WIRE CORRECTLY WITH THIS COOK IRELAND DEVICE. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTING. HOWEVER, POSSIBLE ROOT CAUSES MAY BE THE COMPETITORS WIRE GUIDE WAS NOT POSITIONED CORRECTLY DURING THE PROCEDURE. THIS THEN LED TO THE WIRE GUIDE COVERING BECOMING SHEARED, RESULTING IN BARE WIRE PERFORATING THROUGH COOK IRELAND DEVICE. NOTE: THIS WAS A COMPETITORS WIRE GUIDE, THIS COMPLAINT WILL DEAL WITH THE COOK IRELAND DEVICE ONLY. ANOTHER POSSIBLE ROOT CAUSE MAY BE STENT REPOSITIONING-USER ERROR. AS STATED IN THE ADDITIONAL QUESTIONS: QUESTION: ¿WHERE WAS THE BALLOON POSITIONED FOR MOVING THE STENT? I.E DID THEY PLACE THE BALLOON THROUGH THE STENT AND EXPAND IT ON THE FAR SIDE FOLLOWED BY PULLING IT BACK OR DID THEY EXPAND THE BALLOON WITHIN THE STENT TO MOVE IT?" ANSWER: "THE BALLOON WAS EXPANDED WITHIN THE STENT TO REMOVE¿ INSTRUCTIONS FOR USE, STATES: ¿THIS STENT IS NOT INTENDED TO BE REMOVED AND IS CONSIDERED A PERMANENT IMPLANT. ATTEMPTS TO REMOVE THE STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO THE SURROUNDING MUCOSA.¿ ¿TO REPOSITION THE STENT, THE STENT MUST FIRST BE RECAPTURED AND THE ELEVATOR MUST BE OPEN. NOTE: DO NOT PUSH FORWARD ON THE DELIVERY SYSTEM WITH STENT PARTIALLY DEPLOYED. PUSH DIRECTION BUTTON ON SIDE OF DELIVERY HANDLE TO OPPOSITE SIDE. NOTE: HOLD THUMB ON BUTTON WHEN SQUEEZING TRIGGER FOR FIRST TIME TO RECAPTURE. CONTINUE SQUEEZING TRIGGER AS REQUIRED TO RECAPTURE STENT BY DESIRED AMOUNT.¿ ¿IF STENT REPOSITIONING IS REQUIRED DURING DEPLOYMENT, IT IS POSSIBLE TO RECAPTURE STENT. NOTE: IT IS NOT POSSIBLE TO RECAPTURE STENT AFTER PASSING POINT-OF-NO-RETURN, INDICATED WHEN RED MARKER ON TOP OF HANDLE HAS PASSED THE POINT-OF-NO-RETURN INDICATOR ON HANDLE LABEL.¿ EXPANDING A BALLOON WITHIN THE STENT TO REMOVE MAY HAVE LED TO PATIENT INJURY. DOCUMENT REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-FC-10-11-6-B OF LOT NUMBER C1435219 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. 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. WORK INSTRUCTION INCLUDES A FUNCTIONAL TEST: ¿DEPLOY THE STENT APPROXIMATELY 50% AND RECAPTURE IT TO ENSURE IT FUNCTIONS CORRECTLY.¿ MANUFACTURING TEAM MEMBERS (MTM) ARE INSTRUCTED AS FOLLOWS: ¿INSPECT FOR VISUAL DEFECTS; I.E. LOOSE OR EMBEDDED FOREIGN MATERIALS, ROUGH OR SHARP EDGES, KINKS¿ ¿VISUAL INSPECTIONS OF PRODUCT AND PACKAGING¿ THE RELEVANT MTM IS INSTRUCTED TO CHECK FOR ¿VISUAL IRREGULARITIES SUCH AS HOLES, DENTS, KINKS OR TEARS.¿ A REVIEW OF RELEVANT MANUFACTURING RECORDS FOR LOT C1435219 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. IFU REVIEW: AS PER THE INSTRUCTIONS FOR USE, STATES: ¿THIS STENT IS NOT INTENDED TO BE REMOVED AND IS CONSIDERED A PERMANENT IMPLANT. ATTEMPTS TO REMOVE THE STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO THE SURROUNDING MUCOSA.¿ ¿TO REPOSITION THE STENT, THE STENT MUST FIRST BE RECAPTURED AND THE ELEVATOR MUST BE OPEN. NOTE: DO NOT PUSH FORWARD ON THE DELIVERY SYSTEM WITH STENT PARTIALLY DEPLOYED. PUSH DIRECTION BUTTON ON SIDE OF DELIVERY HANDLE TO OPPOSITE SIDE. NOTE: HOLD THUMB ON BUTTON WHEN SQUEEZING TRIGGER FOR FIRST TIME TO RECAPTURE. CONTINUE SQUEEZING TRIGGER AS REQUIRED TO RECAPTURE STENT BY DESIRED AMOUNT.¿ ¿IF STENT REPOSITIONING IS REQUIRED DURING DEPLOYMENT, IT IS POSSIBLE TO RECAPTURE STENT. NOTE: IT IS NOT POSSIBLE TO RECAPTURE STENT AFTER PASSING POINT-OF-NO-RETURN, INDICATED WHEN RED MARKER ON TOP OF HANDLE HAS PASSED THE POINT-OF-NO-RETURN INDICATOR ON HANDLE LABEL.¿ EXPANDING A BALLOON WITHIN THE STENT TO REMOVE MAY HAVE LED TO PATIENT INJURY. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. PATIENT DIED DUE TO COMPLICATIONS OF BLEEDING DUE TO THE CASCADING OF EVENTS NOTED DURING THE PROCEDURE (DATE OF PT DEATH NOT SUPPLIED; WCA PRODUCT MANAGER BELIEVES IT WAS AT LEAST 4 OR 5 DAYS AFTER THE COMPLAINT EVENT). COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510(K) NUMBER: K121430. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. THIS FOLLOW UP IS BEING SUBMITTED AS A CORRECTION REPORT TO AMEND THE IFU REFERENCE NUMBER FROM THE INVESTIGATION FINDINGS IN THE PREVIOUS REPORT. DEVICE EVALUATION: THE EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1435219 WAS RETURNED TO CIRL AND EVALUATED ON 04 JULY 2018. HOWEVER, THE STENT OF THIS DEVICE WAS NOT RETURNED AS IT REMAINED IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED: 1. WHAT OTHER DEVICES WERE USED (USING SAME WIRE GUIDE), IN ADVANCE OF USING THE COOK IRL DEVICE? THE BOSTON TRAPEZOID BASKET. 2. CAN THEY DESCRIBE FULLY THE PROCEDURE(S) DONE ON THE PATIENT (FROM START TO FINISH) I.E. WAS A SPHINCTEROTOMY PERFORMED, WERE THERE STONES REMOVED OR LITHOTRIPSY ETC? (NEW QUESTION ADDED POST LAB). COOK ZIMMON DOUBLE PIGTAIL STENT REMOVED INITIALLY USING A SNARE, TRAPEZOID EXTRACTION BASKET USED TO REMOVE POTENTIALLY A STONE OF SLUDGE. 3. COULD THEY ESTIMATE HOW FAR BEYOND THE STRICTURE WAS THE WIREGUIDE FOLLOWING CANNULATION? UNKNOWN. 4. WAS THE WIRE GUIDE ALWAYS VISIBLE EXITING BEYOND THE TIP OF THE DELIVERY SYSTEM OR DID THE WIRE GUIDE COME BACK WITHIN DELIVERY SYSTEM AT SOME POINT. AND REQUIRE TO BE PUSHED FORWARD AGAIN? UNKNOWN- WOULD NEED TO CLARIFY WITH THE SURGEON. 5. WAS THE WIRE GUIDE LOCKED ON A WIRE LOCK DURING DEPLOYMENT? NO WIRE LOCK USED. 6. CAN THEY CONFIRM IF THE YELLOW MARKER WAS INSIDE OF THE DUCT WHEN THE STENT WAS BEING DEPLOYED? NEED TO CONFIRM. 7. CAN THEY CONFIRM THAT THERE WAS NO ISSUE WITH STENT DEPLOYMENT? NO ISSUE WITH STENT DEPLOYMENT. 8. WAS THE REMOVAL OF THE DEVICE ATTEMPTED WITH THE WIRE LOCKED IN A WIRE LOCK? NO. 9. WAS THE DEVICE AND WIREGUIDE REMOVED FROM THE PATIENT THROUGH THE SCOPE CHANNEL OR WAS THE ENDOSCOPE REMOVED WITH THE DEVICE AND WIREGUIDE AS A SINGLE UNIT. THE DEVICE AND WIRE GUIDE WAS REMOVED THROUGH THE SCOPE CHANNEL. 10. WHERE WAS THE BALLOON POSITIONED FOR MOVING THE STENT? I.E. DID THEY PLACE THE BALLOON. THROUGH THE STENT AND EXPAND IT ON THE FAR SIDE FOLLOWED BY PULLING IT BACK OR DID THEY EXPAND THE BALLOON WITHIN THE STENT TO MOVE IT? THE BALLOON WAS EXPANDED WITHIN THE STENT TO REMOVE. 11. DID THEY PERFORM AN AUTOPSY, WAS THE LOCATION OF THE BLEED FOUND AND IF SO WHERE WAS THE LOCATION OF THE BLEED/PERFORATION? I WILL NEED TO FOLLOW UP ON AUTOPSY RESULTS. DR DID MENTION INITIALLY THERE WAS BLOOD CLOTTING IN THE DUODENUM UPDATE RECEIVED 12 JUNE 2018: WCA PRODUCT MANAGER TELEPHONED WCA CUSTOMER RELATIONS TO REPORT THAT THE DR INFORMED COOK SBU THAT DAY THAT THE PATIENT HAD DIED DUE TO COMPLICATIONS OF BLEEDING (DATE OF PT DEATH NOT SUPPLIED; WCA PRODUCT MANAGER BELIEVES IT WAS AT LEAST 4 OR 5 DAYS AFTER THE COMPLAINT EVENT) THE DOCTOR INFORMED THE WCA PRODUCT MANAGER THAT HE BELIEVES THE DELIVERY SYSTEM AND/OR THE STENT CAUSED THE BLEEDING. LAB EVALUATION: UPON EVALUATION OF THE RETURNED DEVICE, THE GUIDE WIRE APPEARED TO BE PROTRUDING FROM THE DEVICES. THERE WAS A KINK IN THE FLEXOR BUT THIS WAS BELIEVED TO BE NOT RELATED AS DEVICE WAS NOT RETURNED IN ORIGINAL PACKAGING. THE SPECIFIC LOCATION OF DEFECTS ON THE DEVICE: WIRE GUIDE WAS EXITING THROUGH POLYAMIDE TUBE DISTAL TO ENDOSCOPIC MARKER AND PROXIMAL TO FIRST MARKER. STENT WAS MISSING AS WAS DEPLOYED WITHIN PATIENT. IT APPEARED THAT THE WIRE GUIDE (WHICH WAS A "COMPETITOR'S" DEVICE) HAD EXITED AT LOCATION DESCRIBED IN COMPLAINT AND CAUSED JAMMING OF THE COOK IRELAND DEVICE. NOTHING WAS FOUND WRONG WITH COOK IRELAND DEVICE. IT APPEARED THAT COATING OF THE GUIDE WIRE SHEARED AND WIRE EXITED COOK IRELAND DEVICE. NOTE: RED TAB WAS FULLY BACK. THERE DIDN¿T APPEAR TO BE AN ISSUE WITH DEPLOYMENT. NO DAMAGE TO LOCK WIRE. THE DEFECT WAS VISUALLY CONFIRMED, WIRE GUIDE HAD PERFORATED THROUGH COOK IRELAND DEVICE, WHICH LED TO JAMMING. FURTHER INVESTIGATION: FURTHER ENGINEERING INVESTIGATION AND TESTING: THE PERFORATION OF THE POLYIMIDE TUBE CAN BE ATTRIBUTED TO THE FOLLOWING SEQUENCE OF EVENTS: (1) THE WIREGUIDE POSITION WAS LOST AT SOME POINT DURING THE PROCEDURE AND IT SLIPPED BACK TO A POSITION PROXIMAL TO THE YELLOW MARKER WITHIN THE DEVICE. AN ATTEMPT WAS MADE TO ADVANCE THE WIREGUIDE FOLLOWING THE LOSS OF WIREGUIDE POSITION. FROM THE COMPLAINT IT IS CLEAR THAT THE STENT WAS PLACED TOO FAR INTO THE DUCT AND REPOSITIONING WAS REQUIRED HENCE THE PHYSICIAN NEEDED TO KEEP THE DUCT CANNULATED TO ENABLE THE INTRODUCTION OF ANOTHER DEVICE FOR REPOSITIONING OF THE STENT FOLLOWING THE REMOVAL OF THE EVOLUTION BILIARY DEVICE. (2) THE OUTER COATING OF THE WIRE GUIDE WAS NOT PRESENT OVER THE WIREGUIDE TIP AS THE USER ATTEMPTED TO ADVANCE THE WIREGUIDE THROUGH THE DEVICE. (THE REASON FOR THE DAMAGED TIP IS UNKNOWN, HOWEVER IT MAY HAVE BEEN DAMAGED BY DEVICES USED EARLIER IN THE PROCEDURE (E.G. BOSTON TRAPEZOID RETRIEVAL BASKET AS OUTLINED IN THE COMPLAINT) AND CANNOT BE ATTRIBUTED TO A DEFECTIVE COOK DEVICE.) (3) AS THE WIRE GUIDE WAS ADVANCED TO THE LOCATION OF THE KINK, THE UNPROTECTED BARE METAL TIP OF THE DEFECTIVE JAGWIRE WIREGUIDE SLICED THROUGH THE POLYIMIDE. AS PER THE INSTRUCTIONS FOR USE, IFU-0062-5 STATES: "REMOVE STENT DELIVERY SYSTEM FROM PACKAGE AND BACKLOAD DEVICE OVER A PREPOSITIONED WIRE GUIDE, ENSURING THAT THE WIRE GUIDE EXITS CATHETER AT ZIP PORT" DIAGRAMS INDICATE AND INSTRUCT THE USER HOW TO USE GUIDE WIRE CORRECTLY WITH THIS COOK IRELAND DEVICE. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTING. HOWEVER, POSSIBLE ROOT CAUSES MAY BE THE COMPETITORS WIRE GUIDE WAS NOT POSITIONED CORRECTLY DURING THE PROCEDURE. THIS THEN LED TO THE WIRE GUIDE COVERING BECOMING SHEARED, RESULTING IN BARE WIRE PERFORATING THROUGH COOK IRELAND DEVICE. NOTE: THIS WAS A "COMPETITOR'S" WIRE GUIDE, THIS COMPLAINT WILL DEAL WITH THE COOK IRELAND DEVICE ONLY. ANOTHER POSSIBLE ROOT CAUSE MAY BE STENT REPOSITIONING-USER ERROR. AS STATED IN THE ADDITIONAL QUESTIONS: QUESTION: ¿WHERE WAS THE BALLOON POSITIONED FOR MOVING THE STENT? I.E DID THEY PLACE THE BALLOON THROUGH THE STENT AND EXPAND IT ON THE FAR SIDE FOLLOWED BY PULLING IT BACK OR DID THEY EXPAND THE BALLOON WITHIN THE STENT TO MOVE IT?" ANSWER: "THE BALLOON WAS EXPANDED WITHIN THE STENT TO REMOVE¿ INSTRUCTIONS FOR USE, IFU-0062-5 STATES: ¿THIS STENT IS NOT INTENDED TO BE REMOVED AFTER INITIAL STENT PLACEMENT PROCEDURE AND IS CONSIDERED A PERMANENT IMPLANT. ATTEMPTS TO REMOVE THE STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO THE SURROUNDING MUCOSA.¿ ¿TO REPOSITION THE STENT, THE STENT MUST FIRST BE RECAPTURED AND THE ELEVATOR MUST BE OPEN. NOTE: DO NOT PUSH FORWARD ON THE DELIVERY SYSTEM WITH STENT PARTIALLY DEPLOYED. PUSH DIRECTION BUTTON ON SIDE OF DELIVERY HANDLE TO OPPOSITE SIDE. NOTE: HOLD THUMB ON BUTTON WHEN SQUEEZING TRIGGER FOR FIRST TIME TO RECAPTURE. CONTINUE SQUEEZING TRIGGER AS REQUIRED TO RECAPTURE STENT BY DESIRED AMOUNT.¿ ¿IF STENT REPOSITIONING IS REQUIRED DURING DEPLOYMENT, IT IS POSSIBLE TO RECAPTURE STENT. NOTE: IT IS NOT POSSIBLE TO RECAPTURE STENT AFTER PASSING POINT-OF-NO-RETURN, INDICATED WHEN RED MARKER ON TOP OF HANDLE HAS PASSED THE POINT-OF-NO-RETURN INDICATOR ON HANDLE LABEL.¿ EXPANDING A BALLOON WITHIN THE STENT TO REMOVE MAY HAVE LED TO PATIENT INJURY. DOCUMENT REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-FC-10-11-6-B OF LOT NUMBER C1435219 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. 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. IFU REVIEW: AS PER THE INSTRUCTIONS FOR USE, IFU-0062-5 STATES: ¿THIS STENT IS NOT INTENDED TO BE REMOVED AFTER INITIAL STENT PLACEMENT PROCEDURE AND IS CONSIDERED A PERMANENT IMPLANT. ATTEMPTS TO REMOVE THE STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO THE SURROUNDING MUCOSA.¿ ¿TO REPOSITION THE STENT, THE STENT MUST FIRST BE RECAPTURED AND THE ELEVATOR MUST BE OPEN. NOTE: DO NOT PUSH FORWARD ON THE DELIVERY SYSTEM WITH STENT PARTIALLY DEPLOYED. PUSH DIRECTION BUTTON ON SIDE OF DELIVERY HANDLE TO OPPOSITE SIDE. NOTE: HOLD THUMB ON BUTTON WHEN SQUEEZING TRIGGER FOR FIRST TIME TO RECAPTURE. CONTINUE SQUEEZING TRIGGER AS REQUIRED TO RECAPTURE STENT BY DESIRED AMOUNT.¿ ¿IF STENT REPOSITIONING IS REQUIRED DURING DEPLOYMENT, IT IS POSSIBLE TO RECAPTURE STENT. NOTE: IT IS NOT POSSIBLE TO RECAPTURE STENT AFTER PASSING POINT-OF-NO-RETURN, INDICATED WHEN RED MARKER ON TOP OF HANDLE HAS PASSED THE POINT-OF-NO-RETURN INDICATOR ON HANDLE LABEL.¿ EXPANDING A BALLOON WITHIN THE STENT TO REMOVE MAY HAVE LED TO PATIENT INJURY. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. PATIENT DIED DUE TO COMPLICATIONS OF BLEEDING DUE TO THE CASCADING OF EVENTS NOTED DURING THE PROCEDURE (DATE OF PT DEATH NOT SUPPLIED; WCA PRODUCT MANAGER BELIEVES IT WAS AT LEAST 4 OR 5 DAYS AFTER THE COMPLAINT EVENT). COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THE STENT WAS DEPLOYED SUCCESSFULLY - BUT DELIVERY SYSTEM WAS COMPLETELY DESTROYED- THE CATHETER WAS NOT "INTACT." THERE WAS DIFFICULTY REMOVING THE CATHETER FROM THE SCOPE INITIALLY FOLLOWING DEPLOYMENT OF THE STENT. THE BOSTON JAG WIRE USED IN THE STENT APPEARED TO BE DAMAGED- IT HAD BEEN SHEERED/SPLINTERED. AS PER THE COMPLAINT FORM: THE CATHETER OF THE STENT WAS COMPLETELY DESTROYED- IT WAS KINKED, INSIDES OF THE CATHETER WAS EXPOSED AND ALSO GUIDEWIRE EXPOSED. THE CATHETER COULD NOT BE REMOVED FROM THE SCOPE INITIALLY- IT WAS HOWEVER REMOVED BY PULLING WITH FORCE. THE NURSE OBSERVED THE BOSTON JAG WIRE AND SAID IT APPEARED TO BE SHEARED. THE JAG GUIDEWIRE HAD BEEN USED IN OTHER DEVICES DURING THE PROCEDURE SUCH AS THE BOSTON TRAPEZOID RETRIEVAL BASKET. THE STENT WAS DEPLOYED SUCCESSFULLY BUT NOT IN THE DESIRED POSITION- TOO HIGH UP IN THE CBD. THIS WAS LATER CORRECTED USING A CRE BALLOON TO PULL THE STENT DOWN SO THE STENT WAS SEEN EXITING THE CBD AND INTO THE DUODENUM. UPDATE RECEIVED 12 JUNE 2018: WCA PRODUCT MANAGER TELEPHONED WCA CUSTOMER RELATIONS TO REPORT THAT THE DR INFORMED COOK SBU THAT DAY THAT THE PATIENT HAD DIED DUE TO COMPLICATIONS OF BLEEDING (DATE OF PT DEATH NOT SUPPLIED; WCA PRODUCT MANAGER BELIEVES IT WAS AT LEAST 4 OR 5 DAYS AFTER THE COMPLAINT EVENT) THE DOCTOR INFORMED THE WCA PRODUCT MANAGER THAT HE BELIEVES THE DELIVERY SYSTEM AND/OR THE STENT CAUSED THE BLEEDING. (B)(4). 12 JUNE 2018
THE STENT WAS DEPLOYED SUCCESSFULLY - BUT DELIVERY SYSTEM WAS COMPLETELY DESTROYED- THE CATHETER WAS NOT "INTACT." THERE WAS DIFFICULTY REMOVING THE CATHETER FROM THE SCOPE INITIALLY FOLLOWING DEPLOYMENT OF THE STENT. THE BOSTON JAG WIRE USED IN THE STENT APPEARED TO BE DAMAGED- IT HAD BEEN SHEERED/SPLINTERED. AS PER THE COMPLAINT FORM: THE CATHETER OF THE STENT WAS COMPLETELY DESTROYED- IT WAS KINKED, INSIDES OF THE CATHETER WAS EXPOSED AND ALSO GUIDEWIRE EXPOSED. THE CATHETER COULD NOT BE REMOVED FROM THE SCOPE INITIALLY- IT WAS HOWEVER REMOVED BY PULLING WITH FORCE. THE NURSE OBSERVED THE BOSTON JAG WIRE AND SAID IT APPEARED TO BE SHEARED. THE JAG GUIDEWIRE HAD BEEN USED IN OTHER DEVICES DURING THE PROCEDURE SUCH AS THE BOSTON TRAPEZOID RETRIEVAL BASKET. THE STENT WAS DEPLOYED SUCCESSFULLY BUT NOT IN THE DESIRED POSITION- TOO HIGH UP IN THE CBD. THIS WAS LATER CORRECTED USING A CRE BALLOON TO PULL THE STENT DOWN SO THE STENT WAS SEEN EXITING THE CBD AND INTO THE DUODENUM. UPDATE RECEIVED 12 JUNE 2018: WCA PRODUCT MANAGER TELEPHONED WCA CUSTOMER RELATIONS TO REPORT THAT THE DR INFORMED COOK SBU THAT DAY THAT THE PATIENT HAD DIED DUE TO COMPLICATIONS OF BLEEDING (DATE OF PT DEATH NOT SUPPLIED; WCA PRODUCT MANAGER BELIEVES IT WAS AT LEAST 4 OR 5 DAYS AFTER THE COMPLAINT EVENT) THE DOCTOR INFORMED THE WCA PRODUCT MANAGER THAT HE BELIEVES THE DELIVERY SYSTEM AND/OR THE STENT CAUSED THE BLEEDING. (B)(4) 12 JUNE 2018
THE STENT WAS DEPLOYED SUCCESSFULLY - BUT DELIVERY SYSTEM WAS COMPLETELY DESTROYED- THE CATHETER WAS NOT IN TACT. THERE WAS DIFFICULTY REMOVING THE CATHETER FROM THE SCOPE INITIALLY FOLLOWING DEPLOYMENT OF THE STENT. THE BOSTON JAG WIRE USED IN THE STENT APPEARED TO BE DAMAGED- IT HAD BEEN SHEERED/SPLINTERED. AS PER THE COMPLAINT FORM: THE CATHETER OF THE STENT WAS COMPLETELY DESTROYED- IT WAS KINKED, INSIDES OF THE CATHETER WAS EXPOSED AND ALSO GUIDEWIRE EXPOSED. THE CATHETER COULD NOT BE REMOVED FROM THE SCOPE INITIALLY- IT WAS HOWEVER REMOVED BY PULLING WITH FORCE. THE NURSE OBSERVED THE BOSTON JAG WIRE AND SAID IT APPEARED TO BE SHEARED. THE JAG GUIDEWIRE HAD BEEN USED IN OTHER DEVICES DURING THE PROCEDURE SUCH AS THE BOSTON TRAPEZOID RETRIEVAL BASKET. THE STENT WAS DEPLOYED SUCCESSFULLY BUT NOT IN THE DESIRED POSITION- TOO HIGH UP IN THE CBD. THIS WAS LATER CORRECTED USING A CRE BALLOON TO PULL THE STENT DOWN SO THE STENT WAS SEEN EXITING THE CBD AND INTO THE DUODENUM. UPDATE RECEIVED 12 JUNE 2018: WCA PRODUCT MANAGER TELEPHONED WCA CUSTOMER RELATIONS TO REPORT THAT THE DR INFORMED COOK SBU THAT DAY THAT THE PATIENT HAD DIED DUE TO COMPLICATIONS OF BLEEDING (DATE OF PT DEATH NOT SUPPLIED; WCA PRODUCT MANAGER BELIEVES IT WAS AT LEAST 4 OR 5 DAYS AFTER THE COMPLAINT EVENT) THE DOCTOR INFORMED THE WCA PRODUCT MANAGER THAT HE BELIEVES THE DELIVERY SYSTEM AND/OR THE STENT CAUSED THE BLEEDING. (B)(4) 12 JUNE 2018
THE STENT WAS DEPLOYED SUCCESSFULLY - BUT DELIVERY SYSTEM WAS COMPLETELY DESTROYED- THE CATHETER WAS NOT "INTACT." THERE WAS DIFFICULTY REMOVING THE CATHETER FROM THE SCOPE INITIALLY FOLLOWING DEPLOYMENT OF THE STENT. THE BOSTON JAG WIRE USED IN THE STENT APPEARED TO BE DAMAGED- IT HAD BEEN SHEERED/SPLINTERED. AS PER THE COMPLAINT FORM: THE CATHETER OF THE STENT WAS COMPLETELY DESTROYED- IT WAS KINKED, INSIDES OF THE CATHETER WAS EXPOSED AND ALSO GUIDEWIRE EXPOSED. THE CATHETER COULD NOT BE REMOVED FROM THE SCOPE INITIALLY- IT WAS HOWEVER REMOVED BY PULLING WITH FORCE. THE NURSE OBSERVED THE BOSTON JAG WIRE AND SAID IT APPEARED TO BE SHEARED. THE JAG GUIDEWIRE HAD BEEN USED IN OTHER DEVICES DURING THE PROCEDURE SUCH AS THE BOSTON TRAPEZOID RETRIEVAL BASKET. THE STENT WAS DEPLOYED SUCCESSFULLY BUT NOT IN THE DESIRED POSITION- TOO HIGH UP IN THE CBD. THIS WAS LATER CORRECTED USING A CRE BALLOON TO PULL THE STENT DOWN SO THE STENT WAS SEEN EXITING THE CBD AND INTO THE DUODENUM. UPDATE RECEIVED 12 JUNE 2018: WCA PRODUCT MANAGER TELEPHONED WCA CUSTOMER RELATIONS TO REPORT THAT THE DR INFORMED COOK SBU THAT DAY THAT THE PATIENT HAD DIED DUE TO COMPLICATIONS OF BLEEDING (DATE OF PT DEATH NOT SUPPLIED; WCA PRODUCT MANAGER BELIEVES IT WAS AT LEAST 4 OR 5 DAYS AFTER THE COMPLAINT EVENT) THE DOCTOR INFORMED THE WCA PRODUCT MANAGER THAT HE BELIEVES THE DELIVERY SYSTEM AND/OR THE STENT CAUSED THE BLEEDING. (B)(4) 12 JUNE 2018.
THIS FOLLOW UP IS BEING SUBMITTED AS A CORRECTION REPORT TO AMEND THE IFU REFERENCE NUMBER FROM THE INVESTIGATION FINDINGS IN THE PREVIOUS REPORT. THE STENT WAS DEPLOYED SUCCESSFULLY - BUT DELIVERY SYSTEM WAS COMPLETELY DESTROYED- THE CATHETER WAS NOT IN TACT. THERE WAS DIFFICULTY REMOVING THE CATHETER FROM THE SCOPE INITIALLY FOLLOWING DEPLOYMENT OF THE STENT. THE BOSTON JAG WIRE USED IN THE STENT APPEARED TO BE DAMAGED- IT HAD BEEN SHEERED/SPLINTERED. AS PER THE COMPLAINT FORM: THE CATHETER OF THE STENT WAS COMPLETELY DESTROYED- IT WAS KINKED, INSIDES OF THE CATHETER WAS EXPOSED AND ALSO GUIDEWIRE EXPOSED. THE CATHETER COULD NOT BE REMOVED FROM THE SCOPE INITIALLY- IT WAS HOWEVER REMOVED BY PULLING WITH FORCE. THE NURSE OBSERVED THE BOSTON JAG WIRE AND SAID IT APPEARED TO BE SHEARED. THE JAG GUIDEWIRE HAD BEEN USED IN OTHER DEVICES DURING THE PROCEDURE SUCH AS THE BOSTON TRAPEZOID RETRIEVAL BASKET. THE STENT WAS DEPLOYED SUCCESSFULLY BUT NOT IN THE DESIRED POSITION- TOO HIGH UP IN THE CBD. THIS WAS LATER CORRECTED USING A CRE BALLOON TO PULL THE STENT DOWN SO THE STENT WAS SEEN EXITING THE CBD AND INTO THE DUODENUM. UPDATE RECEIVED 12 JUNE 2018: WCA PRODUCT MANAGER TELEPHONED WCA CUSTOMER RELATIONS TO REPORT THAT THE DR INFORMED COOK SBU THAT DAY THAT THE PATIENT HAD DIED DUE TO COMPLICATIONS OF BLEEDING (DATE OF PT DEATH NOT SUPPLIED; WCA PRODUCT MANAGER BELIEVES IT WAS AT LEAST 4 OR 5 DAYS AFTER THE COMPLAINT EVENT) THE DOCTOR INFORMED THE WCA PRODUCT MANAGER THAT HE BELIEVES THE DELIVERY SYSTEM AND/OR THE STENT CAUSED THE BLEEDING. (B)(4) 12 JUNE 2018
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 481597 | EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | C1435219 | 10827002231341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |