EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
Report
- Report Number
- 3001845648-2018-00249
- Event Type
- Malfunction
- Date Received
- May 28, 2018
- Report Date
- June 25, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K121430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) (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. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
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: STENT MIGRATED. ADDITIONAL INFORMATION: WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? - OLYMPUS' VISIGLIDE / SIZE UNKNOWN 2. HAD A SPHINCTEROTOMY BEEN PERFORMED PRIOR TO THIS OCCURRENCE? - YES 3. HAD DILATION OF THE OBSTRUCTED AREA BEEN PERFORMED PRIOR TO THIS OCCURRENCE? - NO 4. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? - OLYMPUS' JF-260V 5. PLEASE DESCRIBE THE LOCATION IN THE BODY WHERE THE STENT WAS TO BE PLACED. - COMMON BILE DUCT 6. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE THROUGH THE OBSTRUCTED AREA? - NO 7. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE STENT AND INTRODUCER THROUGH THE OBSTRUCTED AREA? - NO 8. WAS THE INTRODUCER ADVANCED THROUGH THE SIDE OF A PREVIOUSLY PLACED STENT? - REQUESTED BUT NOT PROVIDED. 9. PLEASE ESTIMATE AMOUNT OF TIME THE STENT WAS IN PLACE PRIOR TO THIS OCCURRENCE. - 3-20 DAYS 10. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? - NO 11. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? - NEW STENT WAS PLACED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE PATIENT HAD THE FOLLOWING PRE-EXISTING CONDITIONS: PANCREATIC CANCER DEVICE EVALUATION: THE EVO-FC-10-11-6-B OF UNKNOWN LOT NUMBER WAS UNAVAILABLE FOR EVALUATION. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ROOT CAUSE: THERE WAS NO DEVICE RETURNED FOR INVESTIGATION, AND NO IMAGES AVAILABLE FOR REVIEW THEREFORE A DEFINITE ROOT CAUSE COULD NOT BE DETERMINE. HOWEVER, AS PER JAPANESE PACKAGING INSERT, STENT MIGRATION IS LISTED AS A POTENTIAL SIGNIFICANT ADVERSE EVENT. ADDITIONALLY, THE SALES REP¿S COMMENTS IN PATIENT/EVENT INFO ¿ NOTES SECTION POSSIBLE STATES ROOT CAUSES COULD BE DUE TO STENT¿S AXIAL FORCE, RADIATION THERAPY OR THE PATIENT¿S ANATOMY. DOCUMENT REVIEW: AS THE EVO-FC-10-11-6-B FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-6-B DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IFU REVIEW: AS PER THE JAPANESE PACKAGING INSERT, PRODUCT FAILURES AND ADVERSE EVENTS SECTION: ¿SIGNIFICANT ADVERSE EVENTS THAT CAN OCCUR IN CONJUNCTION WITH BILIARY STENT PLACEMENT INCLUDE BUT ARE NOT LIMITED TO: (4) STENT MIGRATION". THE JAPANESE PACKAGING INSERT 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. ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE PACKAGING INSERT. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE STENT WAS EXPECTED TO BE EXCRETED WITH THE STOOL AND FROM THE INFORMATION PROVIDED, NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE.
INITIAL MDR IS BEING SUBMITTED BASED ON SERIOUS INJURY. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE AS THE STENT MIGRATED PROXIMALLY AND WAS EXCRETED IN THE STOOL. THE STENT WAS PLACED IN THE COMMON BILE DUCT. WHEN THE CUSTOMER TOOK X-RAY SOME DAYS AFTER PLACEMENT, HE FOUND THAT THERE WAS NOT THE STENT WHERE IT WAS PLACED, AND HE DETERMINED THE STENT MIGRATED PROXIMALLY. HE DETERMINED THE STENT WILL BE EXCRETED WITH THE STOOL FROM THE PATIENT BODY AND PLACED A NEW STENT IN THE COMMON BILE DUCT.
MDR IS BEING SUBMITTED UNDER THE PRECEDENCE FOR "STENT MIGRATED".
REPORT IS UPDATED WITH THE INVESTIGATION CONCLUSIONS. STENT MIGRATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390139 | EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |