ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2017-00354
- Event Type
- Malfunction
- Date Received
- August 23, 2017
- Date of Event
- June 13, 2017
- Report Date
- September 21, 2017
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002384801
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- 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 WITH THE INVESTIGATION CONCLUSIONS.
THIS REPORT FORMS PART OF A RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY. INITIAL ANGIOGRAM REVEALED PATIENT HAD A PROXIMAL SFA OCCLUSION WHICH WAS BALLOONED AND THEN STENTED WITH A COOK PTX 6X100, G38481, OVER AN AMPLATZ ES WIRE AND THROUGH A 6F RAABE SHEATH THAT HAD BEEN PLACED UP AND OVER. STENT WAS POST-DILATED WITH .035 BALLOON. RUN OFF REVEALED AN ADDITIONAL LESION IN THE DISTAL SFA. PHYSICIAN INSERTED A 6X80 PTX OVER THE AMPLATZ WIRE BEYOND THE INITIAL STENT, INTENDING TO PRIMARY STENT. NEW STENT GOT STUCK ON THE WIRE. ENTIRE SYSTEM HAD TO BE REMOVED FROM THE SHEATH AND PATIENT IMMEDIATELY COMPLAINED OF 9/10 ABDOMINAL AND BACK PAIN. PHYSICIAN THEN INSERTED A FRESH AES WIRE AND DEPLOYED ANOTHER COOK 6X100 PTX G38481 IN DISTAL SFA WITHOUT INCIDENT, STENT WAS BALLOONED, PATIENT'S PAIN SUBSIDED, AND FINAL POST ANGIO WAS FINE. PATIENT NOW HAS GOOD RUNOFF. PHYSICIAN FEELS PATIENT'S COMPLAINT OF PAIN HAD NOTHING TO DO WITH THE COOK DEVICES.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K)#: P100022/S014. THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
(B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K)#: P100022/S014. THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. THE ZISV6-35-125-6-80-PTX DEVICE OF LOT NUMBER C1291985 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. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A NON-HYDROPHILIC, COOK AMPLATZ WIRE GUIDE (REF (B)(4)) OF 0.035¿ DIAMETER. THE COMPLAINT DEVICE WAS FLUSHED PRIOR TO USE. THE TIME FROM ADVANCING THE COMPLAINT DEVICE TO THE ATTEMPTED WITHDRAWAL WAS IN SECONDS. THE WIRE GUIDE WAS USED EARLIER IN THE SAME PROCEDURE AND WAS WIPED BETWEEN USES. THE COMPLAINT DEVICE DELIVERY CATHETER GOT STUCK ON THE WIRE, AFTER STENT DEPLOYMENT. THE COMPLAINT DEVICE WAS NOT ADVANCED THROUGH A PREVIOUSLY PLACED STENT, AND THE STENT WAS DEPLOYED IN THE PATIENT. THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL STATEMENT: "NO, THERE WAS NO ADDITIONAL STENT PLACED THROUGH THE FIRST STENT. THE ORIGINAL STENT WAS POST DILATED WITH A BALLOON. THE ISSUE WAS WE HAD TO LOOSE WIRE ACCESS THROUGH THE ORIGINAL ZILVER STENT BECAUSE THE DEPLOYMENT SYSTEM FROM THE STENT GOT STUCK ON THE WIRE AFTER WE DEPLOYED THE STENT." ON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DEVICE WAS RETURNED WITH THE WIRE GUIDE STILL LOADED. THE WIRE GUIDE WAS MEASURED AS 0.035¿ DIAMETER. 11CM OF THE WIRE GUIDE WAS SEEN EXITING FROM THE DISTAL END OF THE DEVICE. THE WIRE GUIDE WAS REMOVED, BUT OFFERED RESISTANCE DURING REMOVAL. CONGEALED BLOOD WAS OBSERVED ON THE WIRE GUIDE. THE DEVICE WAS FLUSHED WITH NO ISSUES. A NEW 0.035¿ WIRE GUIDE WAS ADVANCED THROUGH THE DEVICE, WITH NO ISSUES FOUND. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE CONGEALED BLOOD IN THE DEVICE LUMEN. THE CONGEALED BLOOD COULD HAVE BOUND THE WIRE GUIDE INSIDE THE DEVICE LUMEN, CAUSING OR CONTRIBUTING TO THE INABILITY TO WITHDRAW THE COMPLAINT DEVICE OVER THE WIRE GUIDE. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. FROM THE PRODUCT INSTRUCTION FOR USE: ¿FOLLOWING STENT DEPLOYMENT, IF RESISTANCE IN MET DURING THE WITHDRAWAL OF THE DELIVERY SYSTEM, CAREFULLY REMOVE THE DELIVERY SYSTEM AND WIRE GUIDE AS A UNIT¿. 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 C1291985. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED PAIN DUE TO THIS OCCURRENCE, BUT DID NOT REQUIRE MEDICAL INTERVENTION, AND THE PAIN PASSED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THIS FOLLOW UP MDR IS BEING SUBMITTED AS THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. THIS REPORT FORMS PART OF A RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY. INITIAL ANGIOGRAM REVEALED PATIENT HAD A PROXIMAL SFA OCCLUSION WHICH WAS BALLOONED AND THEN STENTED WITH A COOK PTX 6X100, G38481, OVER AN AMPLATZ ES WIRE AND THROUGH A 6F RAABE SHEATH THAT HAD BEEN PLACED UP AND OVER. STENT WAS POST-DILATED WITH .035 BALLOON. RUN OFF REVEALED AN ADDITIONAL LESION IN THE DISTAL SFA. PHYSICIAN INSERTED A 6X80 PTX OVER THE AMPLATZ WIRE BEYOND THE INITIAL STENT, INTENDING TO PRIMARY STENT. NEW STENT GOT STUCK ON THE WIRE. ENTIRE SYSTEM HAD TO BE REMOVED FROM THE SHEATH AND PATIENT IMMEDIATELY COMPLAINED OF 9/10 ABDOMINAL AND BACK PAIN. PHYSICIAN THEN INSERTED A FRESH AES WIRE AND DEPLOYED ANOTHER COOK 6X100 PTX G38481 IN DISTAL SFA WITHOUT INCIDENT, STENT WAS BALLOONED, PATIENT'S PAIN SUBSIDED, AND FINAL POST ANGIO WAS FINE. PATIENT NOW HAS GOOD RUNOFF. PHYSICIAN FEELS PATIENT'S COMPLAINT OF PAIN HAD NOTHING TO DO WITH THE COOK DEVICES.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: THIS REPORT FORMS PART OF A RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY. INITIAL ANGIOGRAM REVEALED PATIENT HAD A PROXIMAL SFA OCCLUSION WHICH WAS BALLOONED AND THEN STENTED WITH A COOK PTX 6X100, (B)(4), OVER AN AMPLATZ ES WIRE AND THROUGH A 6F RAABE SHEATH THAT HAD BEEN PLACED UP AND OVER. STENT WAS POST-DILATED WITH .035 BALLOON. RUN OFF REVEALED AN ADDITIONAL LESION IN THE DISTAL SFA. PHYSICIAN INSERTED A 6X80 PTX OVER THE AMPLATZ WIRE BEYOND THE INITIAL STENT, INTENDING TO PRIMARY STENT. NEW STENT GOT STUCK ON THE WIRE. ENTIRE SYSTEM HAD TO BE REMOVED FROM THE SHEATH AND PATIENT IMMEDIATELY COMPLAINED OF 9/10 ABDOMINAL AND BACK PAIN. PHYSICIAN THEN INSERTED A FRESH AES WIRE AND DEPLOYED ANOTHER COOK 6X100 PTX (B)(4) IN DISTAL SFA WITHOUT INCIDENT, STENT WAS BALLOONED, PATIENT'S PAIN SUBSIDED, AND FINAL POST ANGIO WAS FINE. PATIENT NOW HAS GOOD RUNOFF. PHYSICIAN FEELS PATIENT'S COMPLAINT OF PAIN HAD NOTHING TO DO WITH THE COOK DEVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 594217 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | G38480 | 10827002384801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 DA |