EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
Report
- Report Number
- 3001845648-2023-00512
- Event Type
- Malfunction
- Date Received
- June 29, 2023
- Date of Event
- March 2, 2023
- Report Date
- March 13, 2025
- Manufacturer
- COOK MEDICAL IRELAND
- Product Code
- FGE
- PMA / PMN Number
- K121430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION: USER/USE RELATED COMPLAINTS ARE CONSIDERED FORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF INSTRUCTIONS FOR USE AND/OR LABELLING REQUIREMENTS. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. THIS FILES LISTED WERE CREATED FROM THE ATTACHED JOURNAL ARTICLE YAMADA ET AL 2023. -(B)(4). MILD CHOLECYSTITIS - (B)(4). MODERATE CHOLECYSTITIS AND SEVERE PANCREATITIS EMDR 3001845648-2023-00509. - (B)(4). MILD PANCREATITIS AND MILD/ MODERATE CHOLECYSTITIS .- (B)(4). MODERATE/SEVERE PANCREATITIS EMDR 3001845648-2023-00510. - (B)(4). RECURRENT BILIARY OBSTRUCTION ¿ OCCLUSION EMDR 3001845648-2023-00511 .- (B)(4). RECURRENT BILIARY OBSTRUCTION ¿ MIGRATION EMDR 3001845648-2023-00775 .- (B)(4). RECURRENT BILIARY OBSTRUCTION ¿ KINKING EMDR 3001845648-2023-00776. THIS FILE WAS OPENED TO CAPTURE 9 PATIENTS THAT RECEIVED CHEMOTHERAPY AFTER SEMS PLACEMENT WHICH MAY POTENTIALLY RELATE TO THE EVOLUTION BILIARY DEVICES USED IN THIS STUDY. THE DEVICE EVALUATION FOR THE EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED OF UNKNOWN LOT COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL . THE JAPANESE PACKAGING INSERT (C-ES1608Y02) SUPPLIED WITH THE DEVICE INSTRUCTS THE USER THAT AFTER STENT PLACEMENT, ALTERNATIVE METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND TUMOUR SHRINKAGE SHOULD NOT BE ADMINISTERED THIS MAY INCREASE RISK OF STENT MIGRATION DUE TO TUMOUR SHRINKAGE, STENT EROSION, AND/OR MUCOSAL BLEEDING.¿¿ THE JAPANESE PACKAGING INSERT (C-ES1608Y02) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL. IT IS KNOWN FROM THE AVAILABLE INFORMATION THAT THE PATIENT RECEIVED CHEMOTHERAPY AFTER STENT PLACEMENT. AS PER INSTRUCTIONS FOR USE AFTER STENT PLACEMENT, ALTERNATIVE METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND TUMOUR SHRINKAGE SHOULD NOT BE ADMINISTERED THIS MAY INCREASE RISK OF STENT MIGRATION DUE TO TUMOUR SHRINKAGE, STENT EROSION, AND/OR MUCOSAL BLEEDING. CONFIRMATION OF COMPLAINT . COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/ CORRECTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY OF INVESTIGATION. ACCORDING TO THE LITERATURE STUDY 9 PATIENTS RECEIVED CHEMOTHERAPY POST STENT PLACEMENT. CONFIRMED QUANTITY OF 9 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL.
SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE CONFIRMATION FROM QE RECEIVED ON 13-MAR-2025 THAT THE COMPLAINT DID NOT GO AGAINST THE STEPS OUTLINED IN THE IFU FOR THE SAFE & CORRECT USE OF THE DEVICE. ADVISING ''AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOUR SHRINKAGE, STENT EROSION, AND/OR MUCOSAL BLEEDING". THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. DEVICE EVALUATION USER/USE RELATED COMPLAINTS ARE CONSIDERED FORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF INSTRUCTIONS FOR USE AND/OR LABELLING REQUIREMENTS. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. (B)(4) MILD CHOLECYSTITIS, (B)(4) MODERATE CHOLECYSTITIS AND SEVERE PANCREATITIS (B)(4) MILD PANCREATITIS AND MILD/ MODERATE CHOLECYSTITIS (B)(4) MODERATE/SEVERE PANCREATITIS (B)(4) RECURRENT BILIARY OBSTRUCTION OCCLUSION (B)(4) RECURRENT BILIARY OBSTRUCTION, MIGRATION (B)(4) RECURRENT BILIARY OBSTRUCTION, KINKING THIS FILE WAS OPENED TO CAPTURE 9 PATIENTS THAT RECEIVED CHEMOTHERAPY AFTER SEMS PLACEMENT WHICH MAY POTENTIALLY RELATE TO THE EVOLUTION BILIARY DEVICES USED IN THIS STUDY. THE DEVICE EVALUATION FOR THE EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED OF UNKNOWN LOT COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL THE JAPANESE PACKAGING INSERT (C-ES1608Y02) SUPPLIED WITH THE DEVICE INSTRUCTS THE USER THAT AFTER STENT PLACEMENT, ALTERNATIVE METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND TUMOUR SHRINKAGE SHOULD NOT BE ADMINISTERED THIS MAY INCREASE RISK OF STENT MIGRATION DUE TO TUMOUR SHRINKAGE, STENT EROSION, AND/OR MUCOSAL BLEEDING.¿¿ THE JAPANESE PACKAGING INSERT (C-ES1608Y02) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL. IT IS KNOWN FROM THE AVAILABLE INFORMATION THAT THE PATIENT RECEIVED CHEMOTHERAPY AFTER STENT PLACEMENT. AS PER INSTRUCTIONS FOR USE AFTER STENT PLACEMENT, ALTERNATIVE METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND TUMOUR SHRINKAGE SHOULD NOT BE ADMINISTERED THIS MAY INCREASE RISK OF STENT MIGRATION DUE TO TUMOUR SHRINKAGE, STENT EROSION, AND/OR MUCOSAL BLEEDING. CONFIRMATION OF COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/ CORRECTION COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY OF INVESTIGATION ACCORDING TO THE LITERATURE STUDY 9 PATIENTS RECEIVED CHEMOTHERAPY POST STENT PLACEMENT. CONFIRMED QUANTITY OF 9 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL.
YAMADA ET. AL, 2023 ¿ OUTCOMES OF INTRADUCTAL PLACEMENT OF COVERED METAL STENTS FOR UNRESECTABLE DISTAL MALIGNANT BILIARY OBSTRUCTION. WE CONDUCTED A RETROSPECTIVE STUDY OF CONSECUTIVE PATIENTS WITH UNRESECTABLE DISTAL MBO WHO UNDERWENT INITIAL CMS PLACEMENT AT OUR INSTITUTION BETWEEN JUNE 2015 AND MAY 2022. THE METHOD OF SEMS PLACEMENT (ABOVE OR ACROSS THE PAPILLA) WAS LEFT TO THE ENDOSCOPIST¿S DISCRETION. ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WAS PERFORMED USING A THERAPEUTIC DUODENOSCOPE (JF260V, TJF260V, TJF-Q290V; OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN) UNDER CONSCIOUS SEDATION. EST WAS GENERALLY PERFORMED IN ALL PATIENTS WHO RECEIVED AN SEMS PLACED ACROSS THE PAPILLA, WHILE IT WAS LESS FREQUENTLY PERFORMED IN PATIENTS WHO RECEIVED INTRADUCTAL SEMS PLACEMENT TO REDUCE DUODENOBILIARY REFLUX. AN SEMS WAS DEPLOYED ABOVE AND ACROSS THE PAPILLA UNDER FLUOROSCOPIC AND ENDOSCOPIC GUIDANCE. THE LENGTH OF THE SEMS WAS SELECTED BASED ON CHOLANGIOGRAPHIC FINDINGS.THE FULLY COVERED SEMSS USED IN THIS STUDY WERE AS FOLLOWS: HANAROSTENT BILIARY (M.I.TECH, SOUL, REPUBLIC OF KOREA), EVOLUTION BILIARY CONTROLLED-RELEASE STENT¿FULLY COVERED (COOK MEDICAL, BLOOMINGTON, IN, USA), NITI-S SUPREMO STENT (TAEWOONG MEDICAL, SOUL, REPUBLIC OF KOREA), EGIS BILIARY STENT (SB-KAWASUMI LABORATORIES INC., KANAGAWA, JAPAN), AND BONASTENT M-INTRADUCTAL (STANDARD SCI TECH, SOUL, REPUBLIC OF KOREA). THIS COMPLAINT WAS OPENED TO CAPTURE 9 PATIENTS THAT RECEIVED CHEMOTHERAPY AFTER SEMS PLACEMENT WHICH MAY POTENTIALLY RELATE TO THE EVOLUTION BILIARY DEVICES USED IN THIS STUDY. PATIENT OUTCOME: NO KNOWN ADVERSE EFFECTS REPORTED. 86 PATIENTS, 70 +/- YEARS, 31 MALE, 55 FEMALE.
SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 20-OCT-2023.
SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE CONFIRMATION FROM QE RECEIVED ON 13-MAR-2025 THAT THE COMPLAINT DID NOT GO AGAINST THE STEPS OUTLINED IN THE IFU FOR THE SAFE & CORRECT USE OF THE DEVICE. ADVISING ''AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOUR SHRINKAGE, STENT EROSION, AND/OR MUCOSAL BLEEDING". THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1562448 | EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK MEDICAL IRELAND | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |