ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Report
- Report Number
- 3001845648-2018-00523
- Event Type
- Injury
- Date Received
- November 7, 2018
- Date of Event
- September 7, 2018
- Report Date
- November 7, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002352909
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PMA/510(K) # = P100022/S014. 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) # = P100022/S014 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: ED SUTKOWSKI COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195 IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113 DEVICE EVALUATION THE ZISV6-35-125-7.0-120-PTX DEVICE OF LOT NUMBER C1462385 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. SRS WIRE SEPARATION FROM THE RETRACTION SHEATH KINK IN STABILITY SHEATH IN THE AREA OF STRAIN RELIEF. STABILITY SHEATH WAS REMOVED AND SEPARATION OF THE SECOND LASER CUT IN PROXIMAL INNER WAS NOTED. LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 25 OCTOBER 2018. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL ZISV6 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 C1462385. IT MAY BE NOTED THAT THE PRODUCT INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿IF RESISTANCE IS MET DURING ADVANCEMENT OF THE DELIVERY SYSTEM, DO NOT FORCE PASSAGE. REMOVE THE DELIVERY SYSTEM AND REPLACE WITH A NEW DEVICE.¿ ¿A 0.89 MM (0.035 INCH) WIRE GUIDE SHOULD BE USED DURING TRACKING, DEPLOYMENT AND REMOVAL TO ENSURE ADEQUATE SUPPORT OF THE SYSTEM. IF HYDROPHILIC WIRE GUIDES ARE USED, THEY MUST BE KEPT FULLY ACTIVATED.¿ ¿DO NOT USE EXCESSIVE FORCE TO DEPLOY THE STENT. IF EXCESSIVE RESISTANCE IS FELT WHEN BEGINNING DEPLOYMENT, REMOVE THE DELIVERY SYSTEM WITHOUT DEPLOYING THE STENT AND REPLACE WITH A NEW DEVICE.¿ ¿FOLLOWING STENT DEPLOYMENT, IF RESISTANCE IS MET DURING WITHDRAWAL OF THE DELIVERY SYSTEM, CAREFULLY REMOVE THE DELIVERY SYSTEM AND WIRE GUIDE AS A UNIT. IF RESISTANCE IS STILL ENCOUNTERED DURING REMOVAL OF THE DELIVERY SYSTEM AND THE WIRE GUIDE AS A UNIT, REMOVE THE WIRE GUIDE, DELIVERY SYSTEM AND INTRODUCER SHEATH TOGETHER AS A UNIT.¿ IT MAY BE NOTED THAT STENT STRUT FRACTURE IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE IFU. IT MAY BE NOTED THAT A CAPA HAS BEEN INITIATED TO DOCUMENT AND TRACK THE ACTIONS TAKEN TO INVESTIGATE THE STENT RETRACTION WIRE/STENT RETRACTION SHEATH JOINT 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. STRETCHING AND FRACTURE OF THE ZISV6-35-125-7.0-120-PTX IS CONFIRMED. THIS HAPPENED WHEN THE ENTIRE DELIVERY SYSTEM WAS REMOVED WITH THE STENT ONLY SLIGHTLY DEPLOYED. THIS WOULD BE CONSISTENT WITH THE COMPLAINT OF RETRACTION SHEATH AND RIBBON SEPARATION. 2. THE STRETCHED AND FRACTURED STENT INDICATES THAT EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE DELIVERY SYSTEM. THE SHAPE, CALCIFICATION, AND MOBILITY OF THE BIFURCATION THAT HIGHLY RESISTED DEVICE ADVANCEMENT WOULD HAVE LIKEWISE RESISTED DEVICE RETRACTION. AFTER ZISV6-35-125-7.0-120-PTX WAS ADVANCED THROUGH THE RIGHT COMMON ILIAC ARTERY (CIA) WITH ENOUGH FORCE TO BEND THE CIA STENT, THE RETRACTION SHEATH WOULD HAVE BEEN AT LEAST SCUFFED IF NOT CUT. THE BENT CIA STENT WOULD HAVE ALSO INCREASED FRICTION UPON RETRACTION. THE RESULTING INCREASED FRICTION AND THE DIFFICULT BIFURCATION INCREASED THE NECESSARY DEPLOYMENT FORCE. 3. ENGINEERING ANALYSIS PHOTOGRAPHS INDICATE SHEATH KINKING BETWEEN THE RETRACTION SHEATH AND HANDLE. THE KINK SUGGESTED NEAR THE EXPECTED LOCATION OF THE RETRACTION RIBBON BOND COULD HAVE DAMAGED THE BOND IF IT OCCURRED PRIOR TO DEPLOYMENT. THE USE OF A .018 WIRE RENDERED THE DEVICE MORE SUSCEPTIBLE TO KINKING. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF RETRACTION WIRE SEPARATION WAS IDENTIFIED IN THE LABORATORY. THE STENT STRETCHED AND FRACTURED AS THE PHYSICIAN ATTEMPTED TO REMOVE THE ENTIRE DELIVERY SYSTEM WITH THE PARTIALLY DEPLOYED STENT AFTER THE RETRACTION WIRE SEPARATED FROM THE STENT RETRACTION SHEATH (SRS). AS PER THE IMAGING REVIEW: ¿THE SHAPE, CALCIFICATION, AND MOBILITY OF THE BIFURCATION THAT HIGHLY RESISTED DEVICE ADVANCEMENT WOULD HAVE LIKEWISE RESISTED DEVICE RETRACTION. AFTER ZISV6-35-125-7.0-120-PTX WAS ADVANCED THROUGH THE RIGHT COMMON ILIAC ARTERY (CIA) WITH ENOUGH FORCE TO BEND THE CIA STENT, THE RETRACTION SHEATH WOULD HAVE BEEN AT LEAST SCUFFED IF NOT CUT. THE BENT CIA STENT WOULD HAVE ALSO INCREASED FRICTION UPON RETRACTION. THE RESULTING INCREASED FRICTION AND THE DIFFICULT BIFURCATION INCREASED THE NECESSARY DEPLOYMENT FORCE.¿ SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGE(S). STRETCHING AND FRACTURE OF THE STENT WAS CONFIRMED IN THE IMAGING REVIEW. ALTHOUGH A SECOND PTX STENT WAS PLACED TO COVER THE SECTION OF THE COMPLAINT STENT THAT BROKE, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE ACCORDING TO THE INITIAL REPORTER. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THE PHYSICIAN PERFORMED FEMORAL PUNCTURE ON THE LEFT SIDE AND WENT CONTRALATERAL. THE STENOSIS WAS IN RIGHT FEMORAL ARTERY, THEREFORE SHE TRIED TO PASS IT ANTEROGRADE, BUT SHE DIDN'T SUCCEED. THEN SHE PUNCTURED FEMORAL ARTERY IN ADDUCTORY CHANNEL AND PASSED THE LESION IN RETROGRADE DIRECTION AND WENT WITH THE WIRE THROUGH THE SHEATH THAT WAS PLACED ON THE LEFT SIDE. THEN SHE DILATED THE LESION AND THE PUNCTURE SIDE IN ADDUCTORY CHANNEL AND SHE PLACED ZILVER PTX 7X120 MM. THIS STENT BROKE AND A PART OF IT WAS PLACED MORE PROXIMALLY. DUE TO THIS EVENT, SHE PLACED ANOTHER ZILVER PTX (7X80 MM) WHERE THE STENT WAS MISSING.
THE PHYSICIAN PERFORMED FEMORAL PUNCTURE ON THE LEFT SIDE AND WENT CONTRALATERAL. THE STENOSIS WAS IN RIGHT FEMORAL ARTERY, THEREFORE SHE TRIED TO PASS IT ANTEROGRADE, BUT SHE DIDN'T SUCCEED. THEN SHE PUNCTURED FEMORAL ARTERY IN ADDUCTORY CHANNEL AND PASSED THE LESION IN RETROGRADE DIRECTION AND WENT WITH THE WIRE THRUE THE SHEATH THAT WAS PLACED ON THE LEFT SIDE. THEN SHE DILATED THE LESION AND THE PUNCTURE SIDE IN ADDUCTORY CHANNEL AND SHE PLACED ZILVER PTX 7X120 MM. THIS STENT BROKE AND A PART OF IT WAS PLACED MORE PROXIMALLY. DUE TO THIS EVENT, SHE PLACED ANOTHER ZILVER PTX (7X80 MM) WHERE THE STENT WAS MISSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 888807 | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | C1462385 | 10827002352909 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |