UNKNOWN
Report
- Report Number
- 3001845648-2022-00413
- Event Type
- Injury
- Date Received
- July 8, 2022
- Date of Event
- March 8, 2005
- Report Date
- August 11, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS IN PROGRESS AND A FOLLOW UP MDR WILL BE SUBMITTED.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION THE 5X PLASTIC BILIARY STENT OF LOT NUMBER UNKNOWN RPN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW 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. HISTORICAL DATA REVIEW HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IFU & LABEL REVIEW UPON REVIEW OF THE JOURNAL ARTICLE, A TOTAL OF 20 PATIENTS HAD STENTS IMPLANTED TO ASSIST WITH CBD STRICTURES. PROXIMAL OR DISTAL STENT DISLOCATION WAS DETECTED IN 04 (20%) OR 01 (5%) CASES, RESPECTIVELY. TOTAL MIGRATED DEVICES IS 5/20 = 25%. IT SHOULD BE NOTED AS PER IFU0045-7, STENT MIGRATION IS A KNOWN RISK ASSOCIATED WITH BILIARY STENT PLACEMENT: ¿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.¿. IT SHOULD ALSO BE NOTED IN THE PRECAUTIONS SECTION: ¿THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED.¿ AS PER THE MEDICAL ADVISOR, THE STENT MIGRATION WAS CAUSED BY USER ERROR OF EXCEEDING THE INDWELL TIME CALLED OUT IN THE IFU. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AS IT WAS REPORTED IN THE JOURNAL ARTICLE THAT THE STENTS WERE NOT REPLACED AT 3-MONTH INTERVALS. THE PREVIOUS STENT WAS STILL IN PLACE AND WAS NOT EXCHANGED DURING THE SEQUENTIAL INSERTION OF ANOTHER STENT. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF USER ERROR WAS DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE JOURNAL ARTICLE AND CLINICAL INPUT, IT WAS CONFIRMED THAT THE STENTS WERE NOT REPLACED AT 3-MONTH INTERVALS. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IN TOTAL, STENT DISLOCATION/STENT MIGRATION OCCURRED IN 05 PATIENTS (04 PROXIMAL MIGRATIONS AND 01 DISTAL MIGRATION). AS PER CLINICAL INPUT, WHILE THE STENT DISLOCATION WAS DETECTED, NO FURTHER INTERVENTION WAS MENTIONED IN THE JOURNAL ARTICLE HOWEVER, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
DEVICE EVALUATION: THE 5X PLASTIC BILIARY STENT OF LOT NUMBER UNKNOWN RPN AND 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 TO CAPTURE 5 CASES OF ¿STENT DISLOCATION¿. ADDITIONAL COMPLAINT FILE (B)(4) WAS OPENED AS A RESULT OF THIS PAPER TO CAPTURE 5 CASES OF ¿ACUTE CHOLANGITIS¿ AND 9 CASES OF ¿DRAIN CLOGGING¿. LAB EVALUATION: THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW: 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. HISTORICAL DATA REVIEW: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IFU & LABEL REVIEW: UPON REVIEW OF THE JOURNAL ARTICLE, A TOTAL OF 20 PATIENTS HAD STENTS IMPLANTED TO ASSIST WITH CBD STRICTURES. PROXIMAL OR DISTAL STENT DISLOCATION WAS DETECTED IN 04 (20%) OR 01 (5%) CASES, RESPECTIVELY. TOTAL MIGRATED DEVICES IS 5/20 = 25%. IT SHOULD BE NOTED AS PER IFU0045-7, STENT MIGRATION IS A KNOWN RISK ASSOCIATED WITH BILIARY STENT PLACEMENT: ¿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.¿. IT SHOULD ALSO BE NOTED IN THE PRECAUTIONS SECTION: ¿THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED.¿ AS PER THE MEDICAL ADVISOR, THE STENT MIGRATION WAS CAUSED BY USER ERROR OF EXCEEDING THE INDWELL TIME CALLED OUT IN THE IFU THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AS IT WAS REPORTED IN THE JOURNAL ARTICLE THAT THE STENTS WERE NOT REPLACED AT 3-MONTH INTERVALS. THE PREVIOUS STENT WAS STILL IN PLACE AND WAS NOT EXCHANGED DURING THE SEQUENTIAL INSERTION OF ANOTHER STENT. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USER ERROR WAS DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE JOURNAL ARTICLE AND CLINICAL INPUT, IT WAS CONFIRMED THAT THE STENTS WERE NOT REPLACED AT 3-MONTH INTERVALS. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IN TOTAL, STENT DISLOCATION/STENT MIGRATION OCCURRED IN 05 PATIENTS (04 PROXIMAL MIGRATIONS AND 01 DISTAL MIGRATION). AS PER CLINICAL INPUT, WHILE THE STENT DISLOCATION WAS DETECTED, NO FURTHER INTERVENTION WAS MENTIONED IN THE JOURNAL ARTICLE HOWEVER, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
POZSAR ET AL 2005 ¿ ¿ENDOSCOPIC TREATMENT OF SPHINCTEROTOMY-ASSOCIATED DISTAL COMMON BILE DUCT STRICTURES BY USING SEQUENTIAL INSERTION OF MULTIPLE PLASTIC STENTS¿. ALL PATIENTS HAD HIGH-GRADE DISTAL COMMON BILE DUCT STRICTURES EXTENDING UP TO 20 MM PROXIMAL TO THE INTRAMURAL SEGMENT (FIG. 1). A HYDROPHILIC FLUORINATED ETHYLENE-COATED FLEXIBLE GUIDEWIRE (0.035-INCH JAGWIRE; MICROVASIVE ENDOSCOPY, BOSTON SCIENTIFIC CORP, (B)(4)) WAS PASSED THROUGH THE STRICTURE, AND THE STRICTURE THEN WAS DILATED WITH POLYETHYLENE 6F, 8F, OR 10F CATHETERS (WILSON-COOK MEDICAL INC, (B)(4)). THE DIAMETER OF THE DILATION CATHETER WAS DECIDED INDIVIDUALLY, DEPENDING ON THE DIAMETER OF THE STRICTURE AND THAT OF THE PROXIMAL COMMON BILE DUCT. TO EXCLUDE MALIGNANCY, WE OBTAINED INTRADUCTAL BRUSH-CYTOLOGY SPECIMENS FROM ALL PATIENTS. AFTER DILATION OF THE STRICTURE TO THE MAXIMUM POSSIBLE DIAMETER, WE INSERTED A SINGLE PLASTIC 7.5F, 8.5F, OR 10F DIAMETER TEFLON-COATED STENT (WILSON-COOK MEDICAL INC, WINSTON-SALEM, NC) THROUGH THE STRICTURE. DURING THE FIRST STENT PLACEMENT SESSION, OUR BASIC INTENTION WAS TO PLACE THE MAXIMUM DIAMETER SINGLE STENT THAT THE STRICTURE ALLOWED. THE PATIENTS THEN UNDERWENT REPEATED ERCPS AT 3-MONTH INTERVALS. IN ALL ERCP SESSIONS, WE EVALUATED THE LENGTH AND THE DIAMETER OF THE STRICTURE BY THE CHOLANGIO-GRAM. IN ALL STENT-PLACEMENT SESSIONS, WE USED A 6F, PLASTIC GUIDE CATHETER TO PASS THE GUIDEWIRE BEYOND THE STRICTURE ALONG THE STENT INSERTED IN THE PREVIOUS SESSION. THE GUIDEWIRE WAS LEFT IN PLACE, AND WE INSERTED ANOTHER STENT WITH THE MAXIMUM POSSIBLE DIAMETER AFTER REPEATED STEPWISE DILATION OVER THE GUIDEWIRE. OUR BASIC INTENTION WAS TO INSERT THE MAXIMUM POSSIBLE NUMBER OF STENTS AND TO REACH THE MAXIMUM DIAMETER FOR DILATION OF THE STRICTURE. PROXIMAL OR DISTAL STENT DISLOCATION WAS DETECTED IN 4 (7.4%) OR ONE (1.8%) CASES, RESPECTIVELY.
THIS FOLLOW UP MDR IS BEING SUBMITTED TO CAPTURE THE CONFIRMATION PROVIDED BY MEDICAL AFFAIRS MANAGER ON 25-OCT-2022: MIGRATION WAS ALSO ATTRIBUTED TO THE USER ERROR. AS A RESULT BELOW CODES IN SECTION 10 ARE UPDATED: HEALTH EFFECT - IMPACT CODE (ANNEX F) FROM F24 TO F26, MEDICAL DEVICE PROBLEM CODE (ANNEX A) FROM A010402 TO A2303.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2023.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE UPDATES MADE TO IMDRF CODING ON 11-AUG-2023 AND SUBSEQUENT COMPETION OF INVESTGATION ON 24 AUG 23.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2104055 | UNKNOWN | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |