COTTON-HUIBREGTSE BILIARY STENT
Report
- Report Number
- 3001845648-2019-00690
- Event Type
- Injury
- Date Received
- December 9, 2019
- Date of Event
- April 5, 2018
- Report Date
- May 5, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Adverse Event
- Yes
- 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.
CONTACT PERSON: (B)(6) , MD, PHD USER FACILITY: (B)(6) . DEVICE EVALUATION: THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. TWENTY PATIENTS WERE INCLUDED. 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). (B)(4)WAS CREATED TO CAPTURE THE BILIARY STENT MIGRATION (EVO-) (REF. ATT. "CAMUS - EFFICACY AND SAFETY OF ENDOBILIARY RADIOFREQUENCY ABLATION FOR THE ERADICATION OF.PDF") AS IT IS UNKNOWN WHETHER THIS WAS AN EVO BILIARY OR A PLASTIC BILIARY STENT THAT MIGRATED, THIS FILE (B)(4)WAS CREATED TO CAPTURE THE PLASTIC BILIARY STENT (COTTON-HUIBREGTSE BILIARY STENT (CHBS) MIGRATION). LAB EVALUATION ¿ N/A. IMAGE REVIEW ¿ N/A. DOCUMENT REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION CHBS-10 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. AS THE CHBS-10 DEVICES FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE ( IFU0045-7)WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "THOSE ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO : TRAUMA TO THE BILIARY TRACT OR DUODENUM, OBSTRUCTION OF THE PANCREATIC DUCT, STENT MIGRATION." THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, STENT MIGRATION IS LISTED AS A POTENTIAL COMPLICATION FOLLOWING THE PLACEMENT OF THIS DEVICE. SUMMARY: CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. CLINICAL PROVIDED THE FOLLOWING ASSESSMENT: ¿THIS ARTICLE DID NOT INDICATE HOW LONG THOSE 2 STENTS WERE IN THE BILE DUCT BEFORE THEY MIGRATED, THE REMAINING STENTS FROM 18 PATIENTS WERE EASILY REMOVED. THEY SYSTEMATICALLY PLACED A BILIARY STENT AT THE END OF RFA PROCEDURE FOR AT LEAST 3 MONTHS. MY IMPRESSION IS THAT THEY ROUTINELY PLACED A STENT AFTER PROCEDURE, IF THE STENT MIGRATED BEFORE 3 MONTHS, THEY UNLIKELY WOULD PLACE ANOTHER STENT BY ANOTHER PROCEDURE, AND THEY WOULD REMOVE THE UNMIGRATED STENTS AT 3 MONTHS. THEREFORE, I WOULD PRESUME THAT THEY DIDN¿T PLACE ANOTHER 2 STENTS INTO THE PATIENTS.¿ COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. AS IT IS UNKNOWN WHETHER THIS WAS AN EVO BILIARY OR A PLASTIC BILIARY STENT THAT MIGRATED, THIS FILE PR285276 WAS CREATED TO CAPTURE THE PLASTIC BILIARY STENT (COTTON-HUIBREGTSE BILIARY STENT (CHBS) MIGRATION). AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION CHBS-10 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 AS THE CHBS-10 DEVICE IS FROM AN UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE , WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "THOSE ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO : TRAUMA TO THE BILIARY TRACT OR DUODENUM, OBSTRUCTION OF THE PANCREATIC DUCT, STENT MIGRATION." A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE IT STATED INTENDED USE IN THIS CASE PROPHYLACTIC USE OF THE DEVICE IT CAN RESULT IN OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. CLINICAL INPUT RECEIVED CONFIRMED THAT THE PROPHYLACTIC USE OF COOK STENT IN THIS ARTICLE WAS OFF-LABEL USE. THE STENT MIGRATION THAT OCCURRED IN 2 PATIENTS WAS SECONDARY TO THE OFF-LABEL USE. 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: (B)(6) 2019. COUNTRY OF ORIGIN: FRANCE. RPN: UNKNOWN (COTTON-HUIBREGTSE BILIARY STENT (CHBS)). CUSTOMER: EXACT CUSTOMER UNKNOWN, 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. 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). TWO PATIENTS (10%) HAD BILIARY STENT MIGRATION. AS IT IS UNKNOWN WHETHER THIS WAS AN EVO BILIARY OR AN PLASTIC BILIARY STENT THAT MIGRATED, TWO PR¿S WILL BE CREATED TO CAPTURE BOTH DEVICES. THIS PR WILL COVER THE PLASTIC BILIARY STENT (COTTON-HUIBREGTSE BILIARY STENT (CHBS)). THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. BASED ONON THE ASSUMPTION THAT INTERVENTION WAS REQUIRED TO RETRIEVE THE TWO MIGRATED STENTS AND/ OR PROLONGED HOSPITALISATION WAS REQUIRED.
DATE AWARE: 12-NOV-2019. COUNTRY OF ORIGIN: FRANCE. RPN: UNKNOWN (COTTON-HUIBREGTSE BILIARY STENT (CHBS)). CUSTOMER: EXACT CUSTOMER UNKNOWN, 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. 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). TWO PATIENTS (10%) HAD BILIARY STENT MIGRATION. AS IT IS UNKNOWN WHETHER THIS WAS AN EVO BILIARY OR AN PLASTIC BILIARY STENT THAT MIGRATED, TWO PR¿S WILL BE CREATED TO CAPTURE BOTH DEVICES. THIS PR WILL COVER THE PLASTIC BILIARY STENT (COTTON-HUIBREGTSE BILIARY STENT (CHBS)). THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. BASED ONON THE ASSUMPTION THAT INTERVENTION WAS REQUIRED TO RETRIEVE THE TWO MIGRATED STENTS AND/ OR PROLONGED HOSPITALISATION WAS REQUIRED.
SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF ADDITIONAL INFORMATION. CLINICAL INPUT RECEIVED CONFIRMED THAT THE PROPHYLACTIC USE OF COOK STENT IN THIS ARTICLE WAS OFF-LABEL USE.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DATE AWARE: 12-NOV-19. COUNTRY OF ORIGIN: FRANCE. RPN: UNKNOWN (COTTON-HUIBREGTSE BILIARY STENT (CHBS)) CUSTOMER: EXACT CUSTOMER UNKNOWN, 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. 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). TWO PATIENTS (10%) HAD BILIARY STENT MIGRATION. AS IT IS UNKNOWN WHETHER THIS WAS AN EVO BILIARY OR AN PLASTIC BILIARY STENT THAT MIGRATED, TWO PR¿S WILL BE CREATED TO CAPTURE BOTH DEVICES. THIS PR WILL COVER THE PLASTIC BILIARY STENT (COTTON-HUIBREGTSE BILIARY STENT (CHBS)). THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. BASED ONON THE ASSUMPTION THAT INTERVENTION WAS REQUIRED TO RETRIEVE THE TWO MIGRATED STENTS AND/ OR PROLONGED HOSPITALISATION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1234116 | COTTON-HUIBREGTSE BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization| R |