EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
Report
- Report Number
- 3001845648-2016-00274
- Event Type
- Injury
- Date Received
- September 27, 2016
- Date of Event
- August 30, 2016
- Report Date
- December 6, 2016
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002231341
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
THIS SPECIFIC EVOLUTION DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS/SETS (EVOLUTION) DEVICES CURRENTLY MARKETED IN THE US. PMA/510(K)# OF SIMILAR DEVICE: K121430. THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.
THIS SPECIFIC EVOLUTION DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS/SETS (EVOLUTION) DEVICES CURRENTLY MARKETED IN THE US. PMA/510(K)# OF SIMILAR DEVICE: K121430. UPON EVALUATION OF THE DEVICE, IT WAS NOTED THAT THE RETRIEVAL LOOP ASSEMBLY WAS BROKEN AT THE SOLDER JOINT. THE RETRIEVAL LOOP WIRE WAS MISSING. THE STENT CARRIER, RETRIEVAL LOOP PUSHER AND RETRIEVAL LOOP SUTURE WERE RETURNED. ACTUATION OF THE HANDLE WAS POSSIBLE. NO LOCKWIRE WAS RETURNED. THE R&D ENGINEER COMMENTED THAT ¿THE JOINT BREAKING WOULD BE IN RELATION TO WHEN THE SCOPE WAS BEING MOVED AROUND AND LOST POSITION.¿ THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE RETRIEVAL LOOP ASSEMBLY WAS BROKEN AT THE SOLDER JOINT. PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-6-B DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT C1250179 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THIS SPECIFIC EVOLUTION DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS/SETS (EVOLUTION) DEVICES CURRENTLY MARKETED IN THE US. PMA/510(K)# OF SIMILAR DEVICE: K121430. UPON EVALUATION OF THE DEVICE IT WAS NOTED THAT THE RETRIEVAL LOOP ASSEMBLY WAS BROKEN AT THE SOLDER JOINT. THE RETRIEVAL LOOP WIRE WAS MISSING. THE STENT CARRIER, RETRIEVAL LOOP PUSHER AND RETRIEVAL LOOP SUTURE WERE RETURNED. ACTUATION OF THE HANDLE WAS POSSIBLE. NO LOCKWIRE WAS RETURNED. THE R&D ENGINEER COMMENTED THAT ¿THE JOINT BREAKING WOULD BE IN RELATION TO WHEN THE SCOPE WAS BEING MOVED AROUND AND LOST POSITION.¿ THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE RETRIEVAL LOOP ASSEMBLY WAS BROKEN AT THE SOLDER JOINT. R&D ENGINEER PROVIDED THE FOLLOWING COMMENTS IN RELATION TO A POSSIBLE CAUSE FOR THE JOINT BREAKAGE: ¿IT IS VERY DIFFICULT TO SAY FOR SURE WHAT CAUSED THE JOINT TO BREAK. ONE POSSIBILITY MIGHT BE THAT IT IS FEASIBLE TO SUGGEST THAT FORCE BEYOND THE DEVICE'S INTENDED DESIGN HAD BEEN USED WHEN TRYING TO DEPLOY STENT. ALSO FROM THE REPORT THE CASE SOUNDED VERY DIFFICULT WITH MULTIPLE ATTEMPTED RECAPTURES OF THE STENT, WHICH MIGHT SUGGEST VERY TORTUROUS ANATOMY OR OTHER FACTORS DURING THE CASE THAT WE ARE NOT AWARE OF WHICH MAY ALSO HAVE LEAD TO THE JOINT BREAKING. PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-6-B DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR LOT C1250179 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THIS IS A FOLLOW UP REPORT, THE INVESTIGATION AND RISK ASSESSMENT IS BEING CARRIED OUT, A FINAL REPORT WILL BE SENT WITHIN 30 DAYS WHEN COMPLETE. THIS IS A FOLLOW UP REPORT, THE INVESTIGATION AND RISK ASSESSMENT IS BEING CARRIED OUT, A FINAL REPORT WILL BE SENT WITHIN 30 DAYS WHEN COMPLETE.
IT WAS REPORTED THAT DURING STENT PLACEMENT THE DOCTOR WANTED TO RECAPTURE THE STENT WHICH WENT VERY WELL. THEY SAW THE STENT IN PAPILLA AND THE DOCTOR ASKED THE NURSE TO DEPLOY THE STENT AND REMOVE THE SAFETY WIRE. THE STENT THEN DISAPPEARED AND MIGRATED INTO THE BILE DUCT. THEY SAW THE BLACK PIECE OF THE CATHETER AND ALSO A PIECE OF WIRE. THE CATHETER WAS BROKEN! THEY REMOVED THE BLACK CATHETER AND THE WHITE WIRE. THEY PLACED ANOTHER FULLY COVERED BOSTON STENT. THIS REPORT ADDRESSES THE INCIDENT OF CATHETER BREAKAGE RESULTING IN SURGICAL INTERVENTION. REFERENCE ALSO REPORT 3001845648-2016-00275 FOR ISSUE OF STENT MIGRATION.
THIS IS A FINAL REPORT FOLLOWING THE COMPLETION OF THE INVESTIGATION. IT WAS REPORTED THAT DURING STENT PLACEMENT THE DOCTOR WANTED TO RECAPTURE THE STENT WHICH WENT VERY WELL. THEY SAW THE STENT IN PAPILLA AND THE DOCTOR ASKED THE NURSE TO DEPLOY THE STENT AND REMOVE THE SAFETY WIRE. THE STENT THEN DISAPPEARED AND MIGRATED INTO THE BILE DUCT. THEY SAW THE BLACK PIECE OF THE CATHETER AND ALSO A PIECE OF WIRE. THE CATHETER WAS BROKEN! THEY REMOVED THE BLACK CATHETER AND THE WHITE WIRE. THEY PLACED ANOTHER FULLY COVERED BOSTON STENT. THIS REPORT ADDRESSES THE INCIDENT OF CATHETER BREAKAGE RESULTING IN SURGICAL INTERVENTION. REPORT 3001845648-2016-00275 WAS SUBMITTED IN RELATION TO THE ISSUE OF STENT MIGRATION. ON COMPLETION OF THE COMPLAINT INVESTIGATION, IT WAS CONCLUDED THAT THE COMPLAINT ISSUE WAS "INCORRECT PLACEMENT" AND NOT "STENT MIGRATION" AS ORIGINALLY REPORTED. THE EVENT (INCORRECT PLACEMENT OF STENT) DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (1997)¿., REFERENCE 3001845648-2016-00275 FOLLOW-UP#1 REPORT FOR DETAILS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF ADDITIONAL COMMENTS FROM R & D ENGINEER WHICH RESULTED IN AN UPDATE TO THE INVESTIGATION. INITIAL INFORMATION: IT WAS REPORTED THAT DURING STENT PLACEMENT THE DOCTOR WANTED TO RECAPTURE THE STENT WHICH WENT VERY WELL. THEY SAW THE STENT IN PAPILLA AND THE DOCTOR ASKED THE NURSE TO DEPLOY THE STENT AND REMOVE THE SAFETY WIRE. THE STENT THEN DISAPPEARED AND MIGRATED INTO THE BILE DUCT. THEY SAW THE BLACK PIECE OF THE CATHETER AND ALSO A PIECE OF WIRE. THE CATHETER WAS BROKEN! THEY REMOVED THE BLACK CATHETER AND THE WHITE WIRE. THEY PLACED ANOTHER FULLY COVERED BOSTON STENT.
THIS IS A FOLLOW UP REPORT, THE INVESTIGATION AND RISK ASSESSMENT IS BEING CARRIED OUT, A FINAL REPORT WILL BE SENT WITHIN 30 DAYS WHEN COMPLETE. IT WAS REPORTED THAT DURING STENT PLACEMENT THE DOCTOR WANTED TO RECAPTURE THE STENT WHICH WENT VERY WELL. THEY SAW THE STENT IN PAPILLA AND THE DOCTOR ASKED THE NURSE TO DEPLOY THE STENT AND REMOVE THE SAFETY WIRE. THE STENT THEN DISAPPEARED AND MIGRATED INTO THE BILE DUCT. THEY SAW THE BLACK PIECE OF THE CATHETER AND ALSO A PIECE OF WIRE. THE CATHETER WAS BROKEN! THEY REMOVED THE BLACK CATHETER AND THE WHITE WIRE. THEY PLACED ANOTHER FULLY COVERED BOSTON STENT. THIS REPORT ADDRESSES THE INCIDENT OF CATHETER BREAKAGE RESULTING IN SURGICAL INTERVENTION. REFERENCE ALSO REPORT 3001845648-2016-00275 FOR ISSUE OF STENT MIGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631752 | EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED | FGE | COOK IRELAND LTD | 10827002231341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |