ZILVER 635 BILIARY SELF EXPANDING METAL STENT
Report
- Report Number
- 3001845648-2019-00330
- Event Type
- Injury
- Date Received
- July 16, 2019
- Date of Event
- June 18, 2019
- Report Date
- August 13, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002506234
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PMA/510(K) #: K163018. 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. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) #: K163018 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). DEVICE EVALUATION THE ZILBS-635-8-8 DEVICE OF LOT NUMBER C1449088 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. IT SHOULD BE NOTED THAT THREE IMAGES WERE ATTACHED TO THE FILE WHICH SHOW A PARTIALLY DEPLOYED STENT THAT APPEARS TO BE DAMAGED. A REQUEST WAS MADE TO DETERMINE IF THE IMAGES WERE OF THE RETURNED DEVICES RELATING TO THIS EVENT OR IF THE IMAGES RELATED TO A DIFFERENT DEVICE. IT WAS CONFIRMED BY THE SALES REP THAT THERE WAS NO OTHER DEVICE INVOLVED IN THESE COMPLAINTS AND THAT THE IMAGES RELATED TO ONE OF THE RELATED COMPLAINT FILES. HOWEVER, IT CANNOT BE CONFIRMED WHICH DEVICE(S) THE IMAGES RELATE TO. LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 11 JULY 2019. ON EVALUATION OF THE DEVICE THE STENT WAS PREMATURELY DEPLOYED (APPROX. 0.5 CM) ON RETURN. THERE WERE NO VISIBLE SIGNS OF COMPRESSION ON THE DEVICE. THE DEVICE WAS FLUSHED AND WIRED WITH A 0.035¿ WIRE GUIDE WITHOUT ISSUE. THE STENT DID NOT APPEAR DAMAGED. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ZILBS-635-8-8 DEVICES ARE SUBJECTED TO A 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 ZILBS-635-8-8 OF LOT NUMBER C1449088 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1449088. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE INSTRUCTS THE USER TO DO THE FOLLOWING; ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. IF THE PACKAGE IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE THE DEVICE. VISUALLY INSPECT THE DEVICE WITH PARTICULAR ATTENTION TO KINKS, BENDS OR BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE THE DEVICE.¿ IMAGE REVIEW ¿ N/A ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DIFFICULT PATIENT ANATOMY. IT IS POSSIBLE THAT A DIFFICULT PATIENT ANATOMY CAUSED AND/OR CONTRIBUTED TO RESISTANCE AND/OR HIGH COMPRESSIVE FORCE ON THE FLEXOR DURING ADVANCEMENT. IT IS POSSIBLE THAT COMPRESSION OF THE FLEXOR RESULTED IN THE PARTIAL PREMATURE DEPLOYMENT OF THE STENT. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. 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.
PMA/510(K) # K163018. 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.
THE STENT PREMATURELY RELEASED 0.5CM DURING ADVANCING THE DELIVERY SYSTEM IN BILE DUCT. THE DEVICE WAS LOCKED BEFORE ADVANCING ENDOSCOPY. USER IS AN EXPERIENCED OPERATOR OF COOK DEVICE. ADDITIONAL INFORMATION PROVIDE 12TH JULY 2019: USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.
THE STENT PREMATURELY RELEASED 0.5CM DURING ADVANCING THE DELIVERY SYSTEM IN BILE DUCT. THE DEVICE WAS LOCKED BEFORE ADVANCING ENDOSCOPY. USER IS AN EXPERIENCED OPERATOR OF COOK DEVICE. ADDITIONAL INFORMATION PROVIDE (B)(6) 2019: USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.
THE STENT PREMATURELY RELEASED 0.5CM DURING ADVANCING THE DELIVERY SYSTEM IN BILE DUCT. THE DEVICE WAS LOCKED BEFORE ADVANCING ENDOSCOPY. USER IS AN EXPERIENCED OPERATOR OF COOK DEVICE. ADDITIONAL INFORMATION PROVIDE 12TH JULY 2019: USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586751 | ZILVER 635 BILIARY SELF EXPANDING METAL STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | G50623 | C1449088 | 10827002506234 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |