ZILVER 635 SELF-EXPANDING BILIARY STENT
Report
- Report Number
- 3001845648-2018-00005
- Event Type
- Malfunction
- Date Received
- January 4, 2018
- Date of Event
- December 7, 2017
- Report Date
- December 8, 2017
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002314853
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
PMA/510(K) # K040505 / K163169. 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. DEVICE EVALUATION: THE ZIB6-40-6.0-30 DEVICE OF LOT NUMBER C1352104 INVOLVED IN THIS COMPLAINT HAS NOT YET BEEN RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE CUSTOMER WAS CONTACTED TO ARRANGE DEVICE RETURN AND TO PROVIDE ADDITIONAL INFORMATION. THE INVESTIGATION WILL BE UPDATED ONCE THE DEVICE HAS BEEN RETURNED AND EVALUATED, OR THE INFORMATION HAS BEEN PROVIDED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A COOK AMPLATZ WIRE GUIDE, OF 0.035¿ DIAMETER. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE A TORTUOUS OR CALCIFIED PATIENT ANATOMY. THE PATIENT ANATOMY COULD HAVE CREATED RESISTANCE, AND CAUSED OR CONTRIBUTED TO THE INABILITY TO DEPLOY THE STENT IN THE PATIENT. HOWEVER, AS THE DEVICE AND THE ADDITIONAL INFORMATION HAVE NOT YET BEEN PROVIDED, AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. DOCUMENT REVIEW: A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1352104) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS 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 C1352104. IT MAY BE NOTED THAT THE FAILURE MODE OF "DEPLOYMENT DIFFICULT" HAS BEEN PROVISIONALLY ASSIGNED. THE FINAL FAILURE MODE WILL BE CONFIRMED FOLLOWING DEVICE RETURN AND EVALUATION. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THE DEVICE WAS USED FOR PTCD. INTRAHEPATIC BILE DUCT WAS PUNCTURED BY MEDIAN APPROACH, THEN THE DELIVERY SYSTEM OF THE DEVICE WAS ADVANCED OVER COOK'S THSF-35-145-AES-SGH TO THE TARGET SITE IN THE INTRAHEPATIC BILE DUCT. THE PHYSICIAN ATTEMPTED TO PULL THE HANDLE IN ORDER TO DEPLOY THE STENT AFTER REMOVING THE SAFETY LOCK, BUT THE HANDLE COULD NOT BE MOVED/PULLED. THEREFORE, THE DEVICE WAS REMOVED OVER THE WIRE GUIDE AND REPLACED WITH ANOTHER ZIB STENT TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. AFTER THAT, THE PHYSICIAN MANIPULATED THE DEVICE TO DEPLOY THE STENT OUTSIDE THE PATIENT, THEN THE STENT COULD BE DEPLOYED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8801 | ZILVER 635 SELF-EXPANDING BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | 10827002314853 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |