ZILVER 635 VASCULAR SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2019-00327
- Event Type
- Malfunction
- Date Received
- July 17, 2019
- Date of Event
- May 18, 2019
- Report Date
- August 13, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- UDI-DI
- 10827002334264
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PMA/510(K) # P050017/S002 AND S003. 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.
PMA/510(K) # P050017/S002 AND S003. 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.
PMA/510(K) # P050017/S002 AND S003. 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 ZIV6-125-8-6.0 DEVICE OF LOT NUMBER C1512841 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. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 04JULY2019. HANDLE FLEXOR SEPARATION WAS NOTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER ZIV6-125-8-6.0 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY AS PER FQC0170. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1512841) 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 C1512841. IT MAY BE NOTED THAT A PROJECT HAS BEEN INITIATED TO PREVENT THE REOCCURRENCE OF BMS FLEXOR SEPARATION. IMAGE REVIEW : IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: IMPRESSION: 1.ALTHOUGH IMPLANTATION OF A ZIV6 PRIMARILY INTO THE DUODENUM IS CONFIRMED, MIGRATION CANNOT BE CONFIRMED AS IMAGING OF THE EVENT WAS NOT PROVIDED. 2. MIGRATION TYPICALLY DESCRIBES STENT MOVEMENT AFTER DEPLOYMENT. THE COMPLAINT DESCRIBES FORWARD MOVEMENT DURING IMPLANTATION. FORWARD STENT MOVEMENT DURING DEPLOYMENT CAN ONLY OCCUR FROM INNER CANULA ADVANCEMENT. THE 10MM OF STENT IS CONSISTENT WITH THIS MECHANISM. 3.ALTHOUGH THE COURSE OF THE STENTS ON THE VIDEO WAS NOT TORTUOUS, THE ANATOMY MAY HAVE BEEN SIGNIFICANTLY STRAIGHTENED BY THE GUIDE WIRE HOWEVER IT IS UNKNOWN WETHER THIS WAS THE GUIDEWIRE AT THE TIME OF THE EVENT. 4. THE EVENT HAS FEATURES SIMILAR TO CCR 2397 WHERE SHEATH AND HANDLE DISCONNECTION WAS OBSERVED WITH STENT AND SHEATH BINDING IN TORTUOUS ANATOMY. THIS COULD CREATE A SITUATION WHERE INNER CANNULA ADVANCEMENT MIGHT OCCUR INADVERTENTLY. 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 OFF LABEL USE, AS THE DEVICE WAS PLACED IN THE BILIARY TRACT . AS STATED IN THE IMAGING REVIEW, SHEATH AND HANDLE DISCONNECTION WAS OBSERVED WITH STENT AND SHEATH BINDING IN TORTUOUS ANATOMY. THIS COULD CREATE A SITUATION WHERE INNER CANNULA ADVANCEMENT MIGHT OCCUR INADVERTENTLY. THEREFORE LINKING THE MIGRATION TO THE HANDLE FLEXOR SEPARATION. ALTHOUGH THE IMAGES OF THE MIGRATION WAS NOT PROVIDED THE CUSTOMER CONFIRMED MIGRATION. 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.
THE CUSTOMER SAID THAT THE TARGET LOCATION OF STENT PLACED WAS IN BILIARY, HOWEVER THE STENT FORWARD MIGRATED ABOUT 4-5CM AND ADVANCED INTO THE INTESTINAL TRACT AS THE SHEATH SEPARATED WHEN THE USER WITHDRAW THE DELIVERY SYSTEM. THEN THE USER PLACED ANOTHER STENT IN THE BILIARY FOR THE PATIENT. THE PATIENT HAS BEEN DISCHARGED FROM HOSPITAL AND ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
THE CUSTOMER SAID THAT THE TARGET LOCATION OF STENT PLACED WAS IN BILIARY, HOWEVER THE STENT FORWARD MIGRATED ABOUT 4-5CM AND ADVANCED INTO THE INTESTINAL TRACT AS THE SHEATH SEPARATED WHEN THE USER WITHDRAW THE DELIVERY SYSTEM. THEN THE USER PLACED ANOTHER STENT IN THE BILIARY FOR THE PATIENT. THE PATIENT HAS BEEN DISCHARGED FROM HOSPITAL AND ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
THE CUSTOMER SAID THAT THE TARGET LOCATION OF STENT PLACED WAS IN BILIARY, HOWEVER THE STENT FORWARD MIGRATED ABOUT 4-5CM AND ADVANCED INTO THE INTESTINAL TRACT AS THE SHEATH SEPARATED WHEN THE USER WITHDRAW THE DELIVERY SYSTEM. THEN THE USER PLACED ANOTHER STENT IN THE BILIARY FOR THE PATIENT. THE PATIENT HAS BEEN DISCHARGED FROM HOSPITAL AND ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 594676 | ZILVER 635 VASCULAR SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | C1512841 | 10827002334264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |