ZILVER 518 VASCULAR SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2018-00468
- Event Type
- Malfunction
- Date Received
- October 3, 2018
- Date of Event
- September 5, 2018
- Report Date
- October 3, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- UDI-DI
- 10827002437910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
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 (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT "WHILE TRYING TO INSERT THE ZILVER 518 THROUGH A .070 SOFIA CATHETER, THE DELIVERY SYSTEM WOULD NOT ADVANCE ANY FURTHER AND MET SIGNIFICANT RESISTANCE WHILE TRYING TO WITHDRAW. UPON REMOVING THE DELIVERY SYSTEM, THE STENT WAS PARTIALLY DEPLOYED AND UNSHEATHED WITHIN THE SYSTEM. HOWEVER, THE RED DEPLOYMENT LOCK HAD NOT BEEN REMOVED AT THE TIME THAT THIS OCCURRED. THE STENT WAS DEPLOYED IN THE STERILE FIELD AND THROWN AWAY DURING CLEAN UP. THE PROCEDURE WAS COMPLETED WITH A NEURON CATHETER AND A DIFFERENT STENT ZILVER 518." DEVICE EVALUATION THE ZIV5-18-125-10-40 DEVICE OF LOT NUMBER C1484389 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL AND A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT A V18 WIRE GUIDE WAS USED WITH THE DEVICE. THE DEVICE WAS FLUSHED AS PER THE IFU PRIOR TO USE. PRE-DILATION WAS NOT PERFORMED. POST-DILATION WAS NOT PERFORMED AS THE STENT WAS NOT DEPLOYED. THE PATIENT¿S ANATOMY WAS DESCRIBED AS TORTUOUS. NO PART OF THE STENT DEPLOYED IN THE ARTERY. FROM THE INFORMATION RECEIVED NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT. IT WAS CONFIRMED THAT THE PHYSICIAN KNOWINGLY USED THE DEVICE IN THE TRANSVERSE SINUSES - A LOCATION THAT IS NOT INDICATED FOR USE. THE PRODUCT MANAGER FOR ZIV5 DEVICES WAS CONTACTED TO CONFIRM WHETHER OR NOT THE 0.070 SOFIA CATHETER WAS COMPATIBLE WITH THE ZIV5 DEVICES. IT WAS CONFIRMED THAT THE CATHETER IS NOT COMPATIBLE WITH THE DEVICE AND MAY HAVE CAUSED OR CONTRIBUTED TO THE RESISTANCE FELT DURING ADVANCEMENT AND WITHDRAWAL OF THE COMPLAINT DEVICE. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 04 OCTOBER 2018. ON EVALUATION OF THE RETURNED DEVICE, THE RED SAFETY LOCK WAS STILL IN PLACE. THE HANDLE CANNULA WAS BENT, WHICH LIKELY OCCURRED DURING RETURN TRANSPORTATION. THE DEVICE FLUSHED AS EXPECTED AND A WIRE GUIDE WAS ADVANCED THROUGH THE DEVICE WITH ONLY SLIGHT RESISTANCE FELT AS IT WAS ADVANCED THROUGH THE BENT CANNULA. THE TIP OF THE DEVICE MAY HAVE GOT CAUGHT ON THE TORTUOUS ANATOMY CAUSING THE PEEK TO STRETCH SLIGHTLY. THE STRETCHED PEEK WOULD HAVE CAUSED THE STENT TO SLIGHTLY DEPLOY PRIOR TO DEPLOYMENT. APPROXIMATELY 7.0 MM OF THE PEEK WAS EXPOSED SUGGESTING THE TIP OF THE DEVICE DID GET CAUGHT ON SOMETHING DURING ADVANCEMENT AND/OR WITHDRAWAL. THE FLEXOR MEASURED 125.2 CM WHICH WAS WITHIN SPECIFICATION OF 125CM +1.3CM -0.8CM. THE OUTER DIAMETER OF THE DEVICE MEASURED 0.0675¿ AT THE END, MIDDLE AND PROXIMAL END OF THE FLEXOR WHICH WAS WITHIN SPECIFICATION OF =0.070¿. THE COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LAB. THE PEEK WAS STRETCHED WHICH WOULD HAVE CAUSED/CONTRIBUTED TO SLIGHT DEPLOYMENT OF THE STENT DURING ADVANCEMENT AND/OR WITHDRAWAL. ROOT CAUSE THE MOST LIKELY ROOT CAUSE FOR THIS COMPLAINT IS OFF LABEL USE. THE USE OF THE DEVICE IN AN AREA THAT IS NOT INDICATED COULD HAVE CAUSED OR CONTRIBUTED TO RESISTANCE DURING ADVANCEMENT AND WITHDRAWAL. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IFU REVIEW IT CAN BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING; ¿THE PRODUCT IS INTENDED FOR USE IN THE ILIAC ARTERIES¿¿ DOCUMENT REVIEW THE ZIV5-18-125-10-40 DEVICE OF LOT NUMBER C1484389 INVOLVED IN THIS COMPLAINT CONTAINS IRST61422-10-40 OF LOT NUMBERS CH1459799 AND CH1465842. PRIOR TO DISTRIBUTION ALL ZIV5 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. PRD REVIEW AS PER (B)(4), THE FOLLOWING STEPS ARE TAKEN TO ENSURE THE STENT IS LOADED INTO THE SYSTEM CORRECTLY AND CHECKED FOR DEFECTS. STEP 7.1 ¿VERIFY THE PRESENCE OF 8 GOLD RIVETS PER STENT BEFORE LOADING.¿ STEP 7.5 ¿SLOWLY EASE THE STENT IN THE TRANSFER SHEATH ON OVER THE PEEK, SO THAT THE LONG LEG IS PUSHED.¿ STEP 7.6 ¿SLOWLY DRAW BACK THE SYSTEM THROUGH THE AUXILIARY TOOL PULLING THE STENT THROUGH WITH YOU UNTIL THE FLEXOR AND STENT ARE LAYING COMPLETELY AGAINST EACH OTHER.¿ STEP 7.8 ¿PUSH THE STENT INTO THE FLEXOR SHEATH BY MEANS OF THE PUSHER PIN TILL THE HANDLE ON THE PUSHER PIN BOTTOMS. IF THE STENT CANNOT BE SUCCESSFULLY TRANSFERRED FROM THE TRANSFER SHEATH TO THE FLEXOR THE STENT MUST BE SCRAPPED.¿ (STENT CANNOT BE REWORKED). A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1484389, CH1459799 AND CH1465842) 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 C1484389. SUMMARY THE COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LAB. THE PEEK WAS STRETCHED WHICH WOULD HAVE CAUSED/CONTRIBUTED TO SLIGHT DEPLOYMENT OF THE STENT DURING ADVANCEMENT AND/OR WITHDRAWAL. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
WHILE TRYING TO INSERT THE ZILVER 518 THROUGH A .070 SOFIA CATHETER, THE DELIVERY SYSTEM WOULD NOT ADVANCE ANY FURTHER AND MET SIGNIFICANT RESISTANCE WHILE TRYING TO WITHDRAW. UPON REMOVING THE DELIVERY SYSTEM, THE STENT WAS PARTIALLY DEPLOYED AND UNSHEATHED WITHIN THE SYSTEM. HOWEVER, THE RED DEPLOYMENT LOCK HAD NOT BEEN REMOVED AT THE TIME THAT THIS OCCURRED. THE STENT WAS DEPLOYED IN THE STERILE FIELD AND THROWN AWAY DURING CLEAN UP. THE PROCEDURE WAS COMPLETED WITH A NEURON CATHETER AND A DIFFERENT STENT ZILVER 518.
WHILE TRYING TO INSERT THE ZILVER 518 THROUGH A .070 SOFIA CATHETER, THE DELIVERY SYSTEM WOULD NOT ADVANCE ANY FURTHER AND MET SIGNIFICANT RESISTANCE WHILE TRYING TO WITHDRAW. UPON REMOVING THE DELIVERY SYSTEM, THE STENT WAS PARTIALLY DEPLOYED AND UNSHEATHED WITHIN THE SYSTEM. HOWEVER, THE RED DEPLOYMENT LOCK HAD NOT BEEN REMOVED AT THE TIME THAT THIS OCCURRED. THE STENT WAS DEPLOYED IN THE STERILE FIELD AND THROWN AWAY DURING CLEAN UP. THE PROCEDURE WAS COMPLETED WITH A NEURON CATHETER AND A DIFFERENT STENT ZILVER 518.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 772098 | ZILVER 518 VASCULAR SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | G43791 | C1484389 | 10827002437910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |