ZILVER 635 BILIARY SELF EXPANDING METAL STENT
Report
- Report Number
- 3001845648-2023-00950
- Event Type
- Malfunction
- Date Received
- December 26, 2023
- Date of Event
- October 20, 2022
- Report Date
- August 25, 2025
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K163018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) #K163018 SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. UPDATE DEVICE NAME. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) #K163018. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO (B)(4)/ MDR REF#3001845648-2023-00949. IT WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE REF. ATT. ¿OKUNO ET AL- 2023 (003).PDF¿ "EFFECT OF URSODEOXYCHOLIC ACID AFTER SELF-EXPANDABLE METAL STENT PLACEMENT IN MALIGNANT DISTAL BILIARY OBSTRUCTION: A PROPENSITY SCORE¿MATCHED COHORT ANALYSIS" AND CAPTURES USER ERRORS OF USE OF INCORRECT WIRE GUIDE & CHEMOTHERAPY. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL ZILBS 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/OR LABEL: THE JAPANESE PACKAGING INSERT C-ES1207M06 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. THIS STATES THE FOLLOWING: "1. USAGE METHOD: EQUIPMENT REQUIRED: DUODENOSCOPE FOR DELIVERY SYSTEM [NOT INCLUDED], DELIVERY SYSTEM WITH APPROPRIATE STENT LENGTH AND DIAMETER, 0.89 MM (0.035 INCH) WIRE GUIDE, COOK FUSION WIRE GUIDE LOCKING DEVICE FOR DELIVERY SYSTEM [NOT INCLUDED] (OPTIONAL)." THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE JAPANESE PACKAGING INSERT. FROM THE INFORMATION PROVIDED IN THE ARTICLE IT IS KNOWN THAT A 0.025¿ WIRE GUIDE WAS USED WITH THE DEVICE IN ALL (B)(4) PATIENTS. IT SHOULD ALSO BE NOTED THAT THE JAPANESE PACKAGING INSERT STATES. ¿¿3) AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOR SHRINKAGE, STENT EROSION OF THE TISSUE, AND/OR MUCOSAL BLEEDING.¿ FROM THE ARTICLE IT IS KNOWN THAT 175 PATIENTS RECEIVED CHEMOTHERAPY AFTER STENT PLACEMENT. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE OF THE USER NOT READING OR FOLLOWING THE JAPANESE PACKAGING INSERT HAS BEEN CONCLUDED. FROM THE INFORMATION PROVIDED IN THE ARTICLE IT IS KNOWN THAT A 0.025¿ WIRE GUIDE WAS USED WITH THE DEVICE IN ALL 475 PATIENTS WHEN THE JAPANESE PACKAGING INSERT PROVIDED WITH THE DEVICE, STATES THAT THE REQUIRED WIRE GUIDE USED BE 0.035.¿ USER/USE RELATED COMPLAINTS IS 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. IT SHOULD ALSO BE NOTED THAT FROM THE ARTICLE IT IS KNOWN THAT 175 PATIENTS RECEIVED CHEMOTHERAPY AFTER STENT PLACEMENT. AS PREVIOUSLY MENTIONED, THE JAPANESE PACKAGING INSERT STATES ¿AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOR SHRINKAGE, STENT EROSION OF THE TISSUE, AND/OR MUCOSAL BLEEDING¿. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL SIMILAR EVENTS. SUMMARY: THE COMPLAINT WAS RAISED FROM LITERATURE PAPER OKUNO ET AL 2023 ¿EFFECT OF URSODEOXYCHOLIC ACID AFTER SELF-EXPANDABLE METAL STENT PLACEMENT IN MALIGNANT DISTAL BILIARY OBSTRUCTION: A PROPENSITY SCORE¿MATCHED COHORT ANALYSIS¿. ACCORDING TO THE PAPER, 175 PATIENTS RECEIVED CHEMOTHERAPY AFTER STENT PLACEMENT, AND A 0.025¿ WIRE GUIDE WAS USED WITH ALL 475 PATIENTS, PATIENT OUTCOMES WERE NOT CONFIRMED IN THE ARTICLE: INVESTIGATION FINDING CONCLUDE A DEFINITIVE ROOT CAUSE OF USER ERROR. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL SIMILAR EVENTS.
(B)(4). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO (B)(4). IT WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE REF. ATT. ¿OKUNO ET AL- 2023 (003).PDF¿ "EFFECT OF URSODEOXYCHOLIC ACID AFTER SELF-EXPANDABLE METAL STENT PLACEMENT IN MALIGNANT DISTAL BILIARY OBSTRUCTION: A PROPENSITY SCORE¿MATCHED COHORT ANALYSIS" AND CAPTURES USER ERRORS OF USE OF INCORRECT WIRE GUIDE & CHEMOTHERAPY. MANUFACTURING RECORDS REVIEW PRIOR TO DISTRIBUTION ALL ZILBS 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/OR LABEL THE JAPANESE PACKAGING INSERT C-ES1207M06 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. THIS STATES THE FOLLOWING: "1. USAGE METHOD EQUIPMENT REQUIRED DUODENOSCOPE FOR DELIVERY SYSTEM [NOT INCLUDED] DELIVERY SYSTEM WITH APPROPRIATE STENT LENGTH AND DIAMETER 0.89 MM (0.035 INCH) WIRE GUIDE COOK FUSION WIRE GUIDE LOCKING DEVICE FOR DELIVERY SYSTEM [NOT INCLUDED] (OPTIONAL)" THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE JAPANESE PACKAGING INSERT. FROM THE INFORMATION PROVIDED IN THE ARTICLE IT IS KNOWN THAT A 0.025¿ WIRE GUIDE WAS USED WITH THE DEVICE IN ALL 475 PATIENTS. (REF. ATT. ¿OKUNO ET AL- 2023 (003).PDF¿ ) IT SHOULD ALSO BE NOTED THAT THE JAPANESE PACKAGING INSERT STATES. ¿¿3) AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOR SHRINKAGE, STENT EROSION OF THE TISSUE, AND/OR MUCOSAL BLEEDING.¿ FROM THE ARTICLE IT IS KNOWN THAT 175 PATIENTS RECEIVED CHEMOTHERAPY AFTER STENT PLACEMENT. (REF. ATT. ¿OKUNO ET AL- 2023 (003).PDF¿ ) IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS A DEFINITIVE ROOT CAUSE OF THE USER NOT READING OR FOLLOWING THE JAPANESE PACKAGING INSERT HAS BEEN CONCLUDED. FROM THE INFORMATION PROVIDED IN THE ARTICLE IT IS KNOWN THAT A 0.025¿ WIRE GUIDE WAS USED WITH THE DEVICE IN ALL 475 PATIENTS WHEN THE JAPANESE PACKAGING INSERT PROVIDED WITH THE DEVICE, STATES THAT THE REQUIRED WIRE GUIDE USED BE 0.035¿. USER/USE RELATED COMPLAINTS IS 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. IT SHOULD ALSO BE NOTED THAT FROM THE ARTICLE IT IS KNOWN THAT 175 PATIENTS RECEIVED CHEMOTHERAPY AFTER STENT PLACEMENT. AS PREVIOUSLY MENTIONED, THE JAPANESE PACKAGING INSERT STATES ¿AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOR SHRINKAGE, STENT EROSION OF THE TISSUE, AND/OR MUCOSAL BLEEDING¿. CONFIRMATION OF COMPLAINT THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL SIMILAR EVENTS. SUMMARY THE COMPLAINT WAS RAISED FROM LITERATURE PAPER OKUNO ET AL 2023 ¿EFFECT OF URSODEOXYCHOLIC ACID AFTER SELF-EXPANDABLE METAL STENT PLACEMENT IN MALIGNANT DISTAL BILIARY OBSTRUCTION: A PROPENSITY SCORE¿MATCHED COHORT ANALYSIS¿. ACCORDING TO THE PAPER, 175 PATIENTS RECEIVED CHEMOTHERAPY AFTER STENT PLACEMENT, AND A 0.025¿ WIRE GUIDE WAS USED WITH ALL 475 PATIENTS, PATIENT OUTCOMES WERE NOT CONFIRMED IN THE ARTICLE INVESTIGATION FINDING CONCLUDE A DEFINITIVE ROOT CAUSE OF USER ERROR. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL SIMILAR EVENTS.
SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. UPDATE DEVICE NAME.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 28 JUN 2024.
OKUNO ET AL 2023¿ EFFECT OF URSODEOXYCHOLIC ACID AFTER SELF-EXPANDABLE METAL STENT PLACEMENT IN MALIGNANT DISTAL BILIARY OBSTRUCTION: A PROPENSITY SCORE¿MATCHED COHORT ANALYSIS THIS STUDY AIMED TO EVALUATE THE EFFICACY OF UDCA AFTER SEMS PLACEMENT FOR MALIGNANT DISTAL BILIARY OBSTRUCTION (MDBO).FOUR HUNDRED SEVENTY-FIVE PATIENTS UNDERWENT PRIMARY SEMS PLACEMENT FOR MDBO SEMS PLACEMENT FOR MDBO WAS PERFORMED USING A STANDARD DUODENOSCOPE (TJF-200, JF-240, JF-260V, OR TJF-260V; OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN). AFTER CHOLANGIOGRAPHY, A GUIDEWIRE (.025-INCH VISIGLIDE2 [OLYMPUS MEDICAL SYSTEMS] OR .025-INCH M-THROUGH [ASAHI INTECC, AICHI, JAPAN]) WAS PLACED ACROSS THE BILIARY STRICTURE. ENDOSCOPIC SPHINCTEROTOMY WAS PERFORMED AFTER PLACING A GUIDEWIRE IF NECESSARY, AFTER WHICH A SEMS WAS PLACED ACROSS THE STRICTURE. THE SEMS TYPE AND PLACEMENT METHOD (ACROSS THE PAPILLA PLACEMENT OR INTRADUCTAL PLACEMENT) WAS SELECTED BY THE MAIN OPERATOR, WITH CONSIDERATION OF THE MDBO LENGTH AND COMMON BILE DUCT DIAMETER. IN SOME CASES, BEFORE DIAGNOSING THE MALIGNANCY, A 5F OR 6F ENDOSCOPIC NASOBILIARY DRAINAGE TUBE (GADELIUS MEDICAL, TOKYO, JAPAN OR COOK MEDICAL INC, TOKYO, JAPAN) OR 7F PLASTIC STENT (THROUGH & PASS [GADELIUS MEDICAL, TOKYO, JAPAN] OR FLEXIMA BILIARY STENT [BOSTON SCIENTIFIC, MARLBOROUGH, MASS, USA]) WAS PLACED BEFORE SEMS PLACEMENT. BASED ON THE HOSPITAL¿S ELECTRONIC MEDICAL RECORDS DATABASE, THE FOLLOWING SEMSS WERE USED FOR MDBO: HANAROSTENT (BOSTON SCIENTIFIC), WALLFLEX (BOSTON SCIENTIFIC), NITI-S SUPREMO STENT (TEAWOONG, SEOUL, KOREA), NITI-S COMVI (TEAWOONG), BONASTENT (STANDARD SCI-TECH, SEOUL, KOREA), BONASTENT M-INTRADUCTAL (STANDARD SCI-TECH), ZILVER 635 BILIARY SELF-EXPANDABLE STENT (COOK MEDICAL, BLOOMINGTON, IND, USA), THESE WERE FURTHER CATEGORIZED AS FOLLOWS: UNCOVERED TYPE STENT (UNCOVERED) ¿ ZILVER 635 STENT. USER ERROR - AFTER CHOLANGIOGRAPHY, A GUIDEWIRE (.025-INCH VISIGLIDE2 [OLYMPUS MEDICAL SYSTEMS] OR .025-INCH M-THROUGH [ASAHI INTECC, AICHI, JAPAN]) WAS PLACED ACROSS THE BILIARY STRICTURE. AS PER IFU0065-4, A 0.035 INCH WIRE GUIDE OF APPROPRIATE LENGTH IS RECOMMENDED USE OF CHEMOTHERAPY AFTER STENT PLACEMENT. PATIENT INFO; CONSECUTIVE PATIENTS AGED =20 YEARS WHO WERE DIAGNOSED WITH MDBO WITH ELEVATED BILIRUBIN OR LIVER ENZYME AND UNDERWENT PRIMARY TRANSPAPILLARY SEMS PLACEMENT BETWEEN 2010 AND 2022 WERE ENROLLED PATIENTS WERE CATEGORIZED BASED ON WHETHER THEY RECEIVED UDCA AFTER SEMS PLACEMENT. HENCE, 1 GROUP DID NOT RECEIVE UDCA AFTER SEMS PLACEMENT (CONTROL GROUP), WHEREAS THE OTHER GROUP RECEIVED CONTINUOUS UDCA AFTER SEMS PLACEMENT (UDCA GROUP).THREE HUNDRED FIFTY-FOUR PATIENTS WERE INCLUDED, OF WHICH 60 RECEIVED UDCA. ADDITIONALLY, WE CONDUCTED A PROPENSITY SCORE¿MATCHED COHORT ANALYSIS ON 110 PATIENTS WITH SEMS PLACEMENT FOR MDBO (MALIGNANT DISTAL BILIARY OBSTRUCTION) TO REDUCE SELECTION BIAS. PATIENTS WERE CATEGORIZED INTO 2 GROUPS OF 55 EACH, BASED ON WHETHER THEY RECEIVED UDCA.
A SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING CORRECTIONS TO THE INVESTIGATION 25 AUG 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2311591 | ZILVER 635 BILIARY SELF EXPANDING METAL STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male |