COTTON-HUIBREGTSE BILIARY STENT
Report
- Report Number
- 3001845648-2019-00691
- Event Type
- Injury
- Date Received
- December 9, 2019
- Date of Event
- April 5, 2018
- Report Date
- March 16, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
DEVICE EVALUATION. THE UNKNOWN DEVICES OF UNKNOWN LOT NUMBERS 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"). (B)(4) WAS CREATED TO CAPTURE THE PLASTIC BILIARY STENT (COTTON-HUIBREGTSE BILIARY STENT (CHBS) MIGRATION). (B)(4) WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO ADDRESS: " THREE CASES OF MILD PANCREATITIS (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)(6) WAS CREATED TO CAPTURE THE PLASTIC BILIARY STENT (COTTON-HUIBREGTSE BILIARY STENT (CHBS)) WHERE THERE WERE THREE CASES OF MILD PANCREATITIS. 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 ERCP INCLUDE, BUT ARE NOT LIMITED TO : PANCREATITIS.". 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. MEDICAL ADVISORY HAS CONFIRMED THAT ¿THE 3 CASES OF MILD ACUTE PANCREATITIS DAY 1 AFTER INTRADUCTAL RADIOFREQUENCY ABLATION (ID-RFA) WERE ID-FRA PROCEDURE RELATED, WHICH WAS NOT RELATED TO COOK STENTS.¿ THEREFORE RISK WILL NOT BE COMPLETE AS THE COOK DEVICES DID NOT CONTRIBUTED TO THE EVENT. SUMMARY: COMPLAINT IS NOT CONFIRMED AS IT HAS BEEN DETERMINED THROUGH MEDICAL INPUT THAT THE COOK DEVICES DID NOT CONTRIBUTE TO THE ISSUE ENCOUNTERED. THE PATIENT OUTCOME IS UNKNOWN. CONSERVATIVE MEDICAL TREATMENT. WAS PROVIDED. 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-19. 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). THREE CASES OF MILD PANCREATITIS (15%) DEVELOPED WITHIN 24 HOURS OF ID-RFA. AS IT IS UNKNOWN WHETHER THIS WAS AN EVO BILIARY OR AN PLASTIC BILIARY STENT THAT WAS PLACED IN THE PATIENTS WITH PANCREATITIS, TWO PR¿S WILL BE CREATED TO CAPTURE BOTH DEVICES. THIS PR WILL COVER THE PLASTIC BILIARY STENT (COTTON-HUIBREGTSE BILIARY STENT (CHBS)).
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 (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). THREE CASES OF MILD PANCREATITIS (15%) DEVELOPED WITHIN 24 HOURS OF ID-RFA. AS IT IS UNKNOWN WHETHER THIS WAS AN EVO BILIARY OR AN PLASTIC BILIARY STENT THAT WAS PLACED IN THE PATIENTS WITH PANCREATITIS, TWO PR¿S WILL BE CREATED TO CAPTURE BOTH DEVICES. THIS PR WILL COVER THE PLASTIC BILIARY STENT (COTTON-HUIBREGTSE BILIARY STENT (CHBS)).
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). 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)(4) USA] OR WALLFLEX [BOSTON SCIENTIFIC, (B)(4), USA]) OR 10F PLASTIC STENTS (CHBS TYPE; COOK MEDICAL). THREE CASES OF MILD PANCREATITIS (15%) DEVELOPED WITHIN 24 HOURS OF ID-RFA. AS IT IS UNKNOWN WHETHER THIS WAS AN EVO BILIARY OR AN PLASTIC BILIARY STENT THAT WAS PLACED IN THE PATIENTS WITH PANCREATITIS, TWO PR¿S WILL BE CREATED TO CAPTURE BOTH DEVICES. THIS PR WILL COVER THE PLASTIC BILIARY STENT (COTTON-HUIBREGTSE BILIARY STENT (CHBS)).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1234115 | COTTON-HUIBREGTSE BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |