ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Report
- Report Number
- 3001845648-2017-00147
- Event Type
- Malfunction
- Date Received
- April 28, 2017
- Date of Event
- March 28, 2017
- Report Date
- May 25, 2017
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002353111
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
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. PMA/510(K) # P100022/S014. THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH 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)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. PMA/510(K) # P100022/S014. THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH 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)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. PMA/510(K) # P100022/S014. THE ZISV6-35-80-6.0-120-PTX DEVICE OF LOT C1306972 WAS RETURNED FOR EVALUATION, WITH THE OPENED ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A 0.035¿ DIAMETER, 180CM TERUMO WIRE GLIDE. THE DEVICE WAS FLUSHED PRIOR TO USE. PRE-DILATION WAS CONDUCTED PRIOR TO THIS OCCURRENCE. THE PATIENT ANATOMY WAS NOT CALCIFIED OR TORTUOUS. ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE OR COMPLAINT DEVICE TO THE TARGET LOCATION. THE DEVICE THUMBWHEEL FAILED WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, AND NO DEPLOYMENT OCCURRED AS A RESULT. NO DAMAGE WAS NOTED ON THE WIRE GUIDE OR COMPLAINT DEVICE BEFORE OR AFTER THIS OCCURRENCE. THE CUSTOMER ALSO STATED THAT THE DEVICE WAS ADVANCED VIA AN IPSILATERAL APPROACH. ON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DEVICE WAS RETURNED WITH THE STENT PARTIALLY DEPLOYED, MATCHING THE CUSTOMER TESTIMONY, THAT THE SYSTEM WAS HANDLED CAUSING PARTIAL DEPLOYMENT. THE DISTANCE BETWEEN THE END OF THE STRAIN RELIEF TO THE WHITE TIP WAS MEASURED TO BE 79.5CM, WHICH WAS IN SPECIFICATION OF 80.0CM +1/-2CM. THE COILS OF THE SRS WAS STRETCHED, WITH THE DISTAL END OF THE STRETCHED COILS MEASURED TO BE 18.3CM FROM THE DISTAL END OF THE STENT RETRACTION SHEATH (SRS). THE ENGINEERS WERE UNABLE TO COMPLETE DEPLOYMENT OF THE STENT IN THE LABORATORY. THE DEVICE HANDLE WAS OPENED IN THE LABORATORY, AND THE STENT RETRACTION WIRE WAS FOUND TO BE PULLED FROM THE SRS. ADDITIONAL CLARIFICATION WAS REQUESTED FROM THE CUSTOMER, TO EXPLAIN THE PARTIAL STENT DEPLOYMENT, AND THE STRETCHING DAMAGE ON THE SRS. THE CUSTOMER STATED THAT THEY COULD HAVE MANUALLY PULLED THE OUTER SHEATH OFF THE DISTAL END OF THE STENT AFTER REMOVAL FROM THE PATIENT. MOREOVER, THE INITIAL INFORMATION STATED THAT THERE WAS NO DAMAGE NOTED ON THE DELIVERY SYSTEM AFTER REMOVING THE DEVICE FROM THE PATIENT AND THAT ACCORDING TO CUSTOMER TESTIMONY, "EVERYTHING LOOKED PERFECTLY NORMAL". BASED ON THIS INFORMATION, IT CAN BE STATED THAT THE DAMAGE TO THE COILS OF THE SRS AND THE PARTIAL STENT DEPLOYMENT COULD HAVE OCCURRED AS THE PHYSICIAN HANDLED THE SHEATH AFTER REMOVAL FROM THE PATIENT. THE CUSTOMER COMPLAINT IS CONFIRMED AS THE STENT COULD NOT BE DEPLOYED IN THE LABORATORY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD THE PATIENT ANATOMY. THE ANATOMY COULD HAVE CREATED HIGH FORCES DURING DEPLOYMENT, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE RETRACTION WIRE SEPARATING FROM THE STENT RETRACTION SHEATH (SRS), AND THE DEVICE FAILING TO DEPLOY THE STENT. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS 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 C1306972. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
WHEN STARTING DEPLOYMENT USING THE THUMB WHEEL, NOTHING HAPPENED, NO STENT DEPLOYMENT, NO SHEATH RETRACTION.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED AS THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A SECOND FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH THE INVESTIGATION CONCLUSIONS. INITIAL REPORT DETAILS: WHEN STARTING DEPLOYMENT USING THE THUMB WHEEL, NOTHING HAPPENED, NO STENT DEPLOYMENT, NO SHEATH RETRACTION.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION INTO THIS EVENT AND AN UPDATE TO THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: WHEN STARTING DEPLOYMENT USING THE THUMB WHEEL, NOTHING HAPPENED, NO STENT DEPLOYMENT, NO SHEATH RETRACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312457 | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | 10827002353111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |