EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
Report
- Report Number
- 3001845648-2019-00701
- Event Type
- Malfunction
- Date Received
- December 10, 2019
- Report Date
- December 1, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K121430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION: THE EVO-FC-10-11-4-B DEVICES OF UNKNOWN LOT NUMBER WERE NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO-FC-10-11-4-B DEVICES FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-4-B DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER THE INSTRUCTIONS FOR USE, IFU0062, WHICH INFORMS THE USER "THIS STENT IS NOT INTENDED TO BE REMOVED AFTER INITIAL STENT PLACEMENT AND IS CONSIDERED AS PERMANENT IMPLANT. ATTEMPTS TO REMOVE THE STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO SURROUNDING MUCOSA¿ ON REVIEW OF THE INFORMATION PROVIDED, THERE IS EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE JOURNAL ARTICLE IT IS KNOWN THAT THE USER USED THE DEVICE OFF-LABEL, AS THE EVO-FC-10-11-4-B DEVICE IS NOT INTENDED TO BE REMOVED AFTER INITIAL STENT PLACEMENT AND IS CONSIDERED A PERMANENT IMPLANT. SUMMARY: CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
DEVICE EVALUATION: THE EVO-FC-10-11-4-B DEVICES OF UNKNOWN LOT NUMBER WERE NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO ADDRESS: "OFF LABEL USE- REMOVAL OF EVO-FC-10-11-4-B" . DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO-FC-10-11-4-B DEVICES FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-4-B DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER THE INSTRUCTIONS FOR USE, IFU0056-5, WHICH INFORMS THE USER "THIS STENT IS NOT INTENDED TO BE REMOVED AFTER INITIAL STENT PLACEMENT AND IS CONSIDERED AS PERMANENT IMPLANT. ATTEMPTS TO REMOVE THE STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO SURROUNDING MUCOSA¿ ON REVIEW OF THE INFORMATION PROVIDED, THERE IS EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE CAUSE COULD BE ATTRIBUTED TO USER ERROR AS THE EVO-FC-10-11-4-B DEVICE IS NOT INTENDED TO BE REMOVED AFTER INITIAL STENT PLACEMENT AND IS CONSIDERED AS PERMANENT IMPLANT. SUMMARY: CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
DATE AWARE: 12-NOV-19. COUNTRY OF ORIGIN: FRANCE. RPN: EVO-FC-10-11-4-B. CUSTOMER: EXACT CUSTOMER UNKNOWN, COULD A NOTE BE MADE IN THE INTERNAL NOTES THAT THE STUDY WAS CONDUCTED IN THREE CENTRE¿S ((B)(6)). PATIENT CONDITIONS: PATIENTS WITH ENDOBILIARY ADENOMA REMNANT SUSPECTED ON EUS OR ERCP AFTER ENDOSCOPIC PAPILLECTOMY WERE CONSIDERED FOR INCLUSION. INCLUSION CRITERIA WERE PRESENCE OF LOW-GRADE DYSPLASIA (LGD) OR HIGH-GRADE DYSPLASIA (HGD) ON BIOPSY SPECIMENS AND/OR BRUSH CYTOLOGY OF THE TERMINAL CBD. BRIEF DESCRIPTION: OFF LABEL USE- REMOVAL OF EVO-FC-10-11-4-B. EVENT DESCRIPTION: TWENTY PATIENTS WERE INCLUDED. THE ENDOBILIARY ADENOMA WAS IN LGD IN 15 PATIENTS AND HGD IN 5 PATIENTS. ALL UNDERWENT 1 SUCCESSFUL ID-RFA SESSION WITH BILIARY STENT PLACEMENT AND RECOVERED UNEVENTFULLY. ALL PATIENTS HAD BILIARY STENT PLACEMENT IMMEDIATELY AFTER IDRFA, 4 OF WHOM RECEIVED A FCSEMS OF 10 MM IN DIAMETER BY 4 CM IN LENGTH AND 16 OF WHOM HAD A 10F PLASTIC STENT IMPLANTED. BILIARY STENT PLACEMENT WAS ACHIEVED WITH FULLY COVERED SELF-EXPANDABLE METAL STENTS (FCSEMSS; EVOLUTION [COOK MEDICAL, (B)(6) USA] OR WALLFLEX [BOSTON SCIENTIFIC, (B)(6) , USA]) OR 10F PLASTIC STENTS (CHBS TYPE; COOK MEDICAL). BILIARY STENTS WERE EASILY RETRIEVED FROM THE 18 REMAINING PATIENTS (80%) AT 3 MONTHS. THIS FILE IS BEING CREATED TO CAPTURE OFF LABEL USE AS EVO-FC-10-11-4-B WAS REMOVED AFTER 3 MONTHS, AS PER THE IFU ¿THIS STENT IS NOT INTENDED TO BE REMOVED AFTER INITIAL STENT PLACEMENT PROCEDURE AND IS CONSIDERED A PERMANENT IMPLANT¿. WE KNOW OF THE 20 STENTS PLACED 4 OF THEM WERE EVO-FC-10-11-4-B THEREFORE SOME OF THE STENTS REMOVED WERE EVO-.
SUPPLEMENT REPORT BEING SUBMITTED DUE TO CORRECTIONS MADE TO G CODE AND COMPLETION OF INVESTIGATION ON THE (B)(6) 2022.
DATE AWARE: 12-NOV-19. COUNTRY OF ORIGIN: FRANCE. RPN: EVO-FC-10-11-4-B CUSTOMER: EXACT CUSTOMER UNKNOWN, COULD A NOTE BE MADE IN THE INTERNAL NOTES THAT THE STUDY WAS CONDUCTED IN THREE CENTRE¿S (HÔPITAL ((B)(6) ). PATIENT CONDITIONS: PATIENTS WITH ENDOBILIARY ADENOMA REMNANT SUSPECTED ON EUS OR ERCP AFTER ENDOSCOPIC PAPILLECTOMY WERE CONSIDERED FOR INCLUSION. INCLUSION CRITERIA WERE PRESENCE OF LOW-GRADE DYSPLASIA (LGD) OR HIGH-GRADE DYSPLASIA (HGD) ON BIOPSY SPECIMENS AND/OR BRUSH CYTOLOGY OF THE TERMINAL CBD. BRIEF DESCRIPTION: OFF LABEL USE- REMOVAL OF EVO-FC-10-11-4-B EVENT DESCRIPTION: TWENTY PATIENTS WERE INCLUDED. THE ENDOBILIARY ADENOMA WAS IN LGD IN 15 PATIENTS AND HGD IN 5 PATIENTS. ALL UNDERWENT 1 SUCCESSFUL ID-RFA SESSION WITH BILIARY STENT PLACEMENT AND RECOVERED UNEVENTFULLY. ALL PATIENTS HAD BILIARY STENT PLACEMENT IMMEDIATELY AFTER IDRFA, 4 OF WHOM RECEIVED A FCSEMS OF 10 MM IN DIAMETER BY 4 CM IN LENGTH AND 16 OF WHOM HAD A 10F PLASTIC STENT IMPLANTED. BILIARY STENT PLACEMENT WAS ACHIEVED WITH FULLY COVERED SELF-EXPANDABLE METAL STENTS (FCSEMSS; EVOLUTION [COOK MEDICAL, (B)(6) USA] OR WALLFLEX [BOSTON SCIENTIFIC, (B)(6) USA]) OR 10F PLASTIC STENTS (CHBS TYPE; COOK MEDICAL). BILIARY STENTS WERE EASILY RETRIEVED FROM THE 18 REMAINING PATIENTS (80%) AT 3 MONTHS THIS FILE IS BEING CREATED TO CAPTURE OFF LABEL USE AS EVO-FC-10-11-4-B WAS REMOVED AFTER 3 MONTHS, AS PER THE IFU ¿THIS STENT IS NOT INTENDED TO BE REMOVED AFTER INITIAL STENT PLACEMENT PROCEDURE AND IS CONSIDERED A PERMANENT IMPLANT¿. WE KNOW OF THE 20 STENTS PLACED 4 OF THEM WERE EVO-FC-10-11-4-B THEREFORE SOME OF THE STENTS REMOVED WERE EVO-.
INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DATE AWARE: 12-NOV-2019. COUNTRY OF ORIGIN: (B)(6). CATALOG #: RPN: EVO-FC-10-11-4-B. CUSTOMER: EXACT CUSTOMER UNKNOWN, COULD A NOTE BE MADE IN THE INTERNAL NOTES THAT THE STUDY WAS CONDUCTED IN THREE CENTRE¿S (HÔPITAL COCHIN, ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS; HÔPITAL PRIVÉ JEAN MERMOZ, LYON; AND CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES). PATIENT CONDITIONS: PATIENTS WITH ENDOBILIARY ADENOMA REMNANT SUSPECTED ON EUS OR ERCP AFTER ENDOSCOPIC PAPILLECTOMY WERE CONSIDERED FOR INCLUSION. INCLUSION CRITERIA WERE PRESENCE OF LOW-GRADE DYSPLASIA (LGD) OR HIGH-GRADE DYSPLASIA (HGD) ON BIOPSY SPECIMENS AND/OR BRUSH CYTOLOGY OF THE TERMINAL CBD. BRIEF DESCRIPTION: OFF LABEL USE- REMOVAL OF EVO-FC-10-11-4-B. EVENT DESCRIPTION: TWENTY PATIENTS WERE INCLUDED. THE ENDOBILIARY ADENOMA WAS IN LGD IN 15 PATIENTS AND HGD IN 5 PATIENTS. ALL UNDERWENT 1 SUCCESSFUL ID-RFA SESSION WITH BILIARY STENT PLACEMENT AND RECOVERED UNEVENTFULLY. ALL PATIENTS HAD BILIARY STENT PLACEMENT IMMEDIATELY AFTER IDRFA, 4 OF WHOM RECEIVED A FCSEMS OF 10 MM IN DIAMETER BY 4 CM IN LENGTH AND 16 OF WHOM HAD A 10F PLASTIC STENT IMPLANTED. BILIARY STENT PLACEMENT WAS ACHIEVED WITH FULLY COVERED SELF-EXPANDABLE METAL STENTS (FCSEMSS; EVOLUTION [COOK MEDICAL, WINSTON-SALEM, NC USA] OR WALLFLEX [BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA]) OR 10F PLASTIC STENTS (CHBS TYPE; COOK MEDICAL). BILIARY STENTS WERE EASILY RETRIEVED FROM THE 18 REMAINING PATIENTS (80%) AT 3 MONTHS. THIS FILE IS BEING CREATED TO CAPTURE OFF LABEL USE AS EVO-FC-10-11-4-B WAS REMOVED AFTER 3 MONTHS, AS PER THE IFU ¿THIS STENT IS NOT INTENDED TO BE REMOVED AFTER INITIAL STENT PLACEMENT PROCEDURE AND IS CONSIDERED A PERMANENT IMPLANT¿. WE KNOW OF THE 20 STENTS PLACED 4 OF THEM WERE EVO-FC-10-11-4-B THEREFORE SOME OF THE STENTS REMOVED WERE EVO-.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1237825 | EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |