EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
Report
- Report Number
- 3001845648-2018-00245
- Event Type
- Malfunction
- Date Received
- May 24, 2018
- Date of Event
- March 27, 2018
- Report Date
- June 21, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002231358
- PMA / PMN Number
- K121430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER CAREGIVERS
Narratives
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT: DURING PROCEDURE OF ERCP, THE PROSTHESIS HAD A PARTIAL OPENING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION RECEIVED: 1. WAS THE DIRECTIONAL BUTTON FULLY ENGAGED? YES 2. DID THE RED CURSOR MOVE WHEN THE TRIGGER WAS PRESSED? YES 3. DID THE RED CURSOR CONTINUE TO MOVE AFTER THE DELIVERY STOPPED? NO 4. WERE ANY CRACKING/POPPING SOUNDS HEARD FROM THE HANDLE? YES 5. WAS THE STENT PARTIALLY DEPLOYED? YES 6. IF THE STENT WAS PARTIALLY EXPOSED, WAS IT POSSIBLE TO RETRACT IT FULLY BEFORE REMOVAL? NO WAS THE INDICATOR (RED) ON THE TOP OF THE DEVICE MOVING WHEN THE TRIGGER WAS ACTUATED? YES WHEN THE STENT WAS NO LONGER DEPLOYING, WAS IT POSSIBLE TO RECAPTURE THE STENT? IT WAS NOT POSSIBLE DID THE DRS FEEL THAT THERE WAS A PROBLEM WITH THE STENT EXPANDING DURING DEPLOYMENT, DID THE STENT EXPAND AS NORMAL? THEY FELT THAT THERE WAS PROBLEM WHEN THE STENT STOPPED COMING OUT AND OPENED IN APPROXIMATELY 20% OF IMPLANTED. Q1. ARE THE DRS SURE THE CURSOR NEVER MOVED AS THEY WERE ADVANCING/DEPLOYING THE STENT? TYPICALLY IF THE STENT WAS ABLE TO BE PARTIALLY DEPLOYED THE CURSOR WOULD HAVE TO MOVE INITIALLY AND THEN MAY/MAY NOT STOP MOVING ONCE THE FAULT OCCURS. DID THE RED CURSOR MOVE INITIALLY AND THEN POSSIBLY STOP MOVING AFTER THE CRACKING SOUND? RECTIFYING THE PREVIOUS RESPONSE, THE RED CURSOR MOVED UNTIL THE STENT STOPS. Q2. APPROX HOW MUCH OF THE STENT DEPLOYED, WERE ANY DIFFICULTIES ENCOUNTERED WHEN RETRACTING? STENT WAS IMPLANTED AROUND 20%. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. DEVICE EVALUATION: THE EVO-FC-10-11-8-B DEVICE OF LOT # C1353083 WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ROOT CAUSE: FROM THE ADDITIONAL INFORMATION PROVIDED THAT THERE WAS CRACKING/POPPING SOUNDS HEARD FROM THE HANDLE AND THAT THE HANDLE DIDN¿T WORK AFTER THAT COULD INDICATE THAT THE DIRECTIONAL BUTTON BECAME DISENGAGED SOMEHOW AT SOME STAGE (MAY BE DUE TO HIGH FORCES REQUIRED DURING THE PROCEDURE) AND THE DIRECTIONAL BUTTON POPPED INTO THE NEUTRAL POSITION AND IN TURN THE GEARS INSIDE THE HANDLE MAY HAVE JAMMED WHICH IN TURN MADE THE HANDLE INOPERABLE. DOCUMENT REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-FC-10-11-8-BOF LOT NUMBER C1353083 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1353083; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1353083. AS PER THE INSTRUCTIONS FOR USE, NOTES SECTION THE USER IS INSTRUCTED OF THE FOLLOWING: ¿IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. FROM THE ADDITIONAL INFORMATION PROVIDED THAT THERE WAS CRACKING/POPPING SOUNDS HEARD FROM THE HANDLE AND THAT THE HANDLE DIDN¿T WORK AFTER THAT COULD INDICATE THAT THE DIRECTIONAL BUTTON BECAME DISENGAGED AT SOME STAGE TO THE NEUTRAL POSITION AND IN TURN THE GEARS INSIDE THE HANDLE MAY HAVE JAMMED WHICH IN TURN MADE THE HANDLE INOPERABLE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
DURING PROCEDURE OF ERCP, THE PROSTHESIS HAD A PARTIAL OPENING, REQUIRING REPLACEMENT BY ANOTHER PROSTHESIS. CONFLICTING INFORMATION HAS BEEN RECEIVED TO DATE, REPORTING CONSERVATIVELY AS WE CANNOT BE SURE A REPORTABLE EVENT DID NOT OCCUR.
REPORT IS SUBMITTED BASED ON THE PRECEDENCE FOR "STENT REMOVED WHILE PARTIALLY EXPOSED". DURING PROCEDURE OF ERCP, THE PROSTHESIS HAD A PARTIAL OPENING, REQUIRING REPLACEMENT BY ANOTHER PROSTHESIS.
REPORT IS SUBMITTED BASED ON THE PRECEDENCE FOR "STENT REMOVED WHILE PARTIALLY EXPOSED". DURING PROCEDURE OF ERCP, THE PROSTHESIS HAD A PARTIAL OPENING, REQUIRING REPLACEMENT BY ANOTHER PROSTHESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 382276 | EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | C1353083 | 10827002231358 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |