EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
Report
- Report Number
- 3001845648-2019-00700
- Event Type
- Injury
- Date Received
- December 10, 2019
- Report Date
- February 20, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K121430
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
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. 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). THIS FILE CAPTURES BILIARY STENT MIGRATION (EVO-) AS IT IS UNKNOWN WHETHER THIS WAS AN EVO BILIARY OR AN PLASTIC BILIARY STENT THAT MIGRATED, (B)(4) WAS CREATED TO CAPTURE THE PLASTIC BILIARY STENT (COTTON-HUIBREGTSE BILIARY STENT (CHBS). 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, IFU0062-5 WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "ADDITIONAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO : STENT MISPLACEMENT AND / OR MIGRATION," ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO 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. INFORMATION RECEIVED IS NOT SUFFICIENT ENOUGH TO CONFIRM THAT IT WAS THE COOK STENT THAT CONTRIBUTED TO THE EVENT. 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. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DATE AWARE: 12-NOV-2019. 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 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: BILIARY STENT MIGRATION (EVO-). 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 FULLY COVERED EVO BILIARY DEVICE (EVO-FC-10-11-4-B). 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 ON THE ASSUMPTION THAT INTERVENTION WAS REQUIRED TO RETRIEVE THE TWO MIGRATED STENTS AND / OR PROLONGED HOSPITALIZATION WAS REQUIRED.
DATE AWARE: 12-NOV-2019. 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: BILIARY STENT MIGRATION (EVO-). 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 FULLY COVERED EVO BILIARY DEVICE (EVO-FC-10-11-4-B). 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 ON THE ASSUMPTION THAT INTERVENTION WAS REQUIRED TO RETRIEVE THE TWO MIGRATED STENTS AND/ OR PROLONGED HOSPITALIZATION WAS REQUIRED.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DATE AWARE: 12-NOV-19. COUNTRY OF ORIGIN: (B)(6). 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: BILIARY STENT MIGRATION (EVO-). 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 FULLY COVERED EVO BILIARY DEVICE (EVO-FC-10-11-4-B) 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 ON THE ASSUMPTION THAT INTERVENTION WAS REQUIRED TO RETRIEVE THE TWO MIGRATED STENTS AND/ OR PROLONGED HOSPITALIZATION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1237827 | EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |