ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Report
- Report Number
- 3001845648-2019-00320
- Event Type
- Injury
- Date Received
- July 12, 2019
- Date of Event
- June 13, 2019
- Report Date
- August 8, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002352855
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
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. DEVICE EVALUATION: THE ZISV6-35-125-6.0-120-PTX DEVICE OF LOT NUMBER C1553848 INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT, AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZISV6-35-125-6.0-120-PTX DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ZISV6-35-125-6.0-120-PTX OF LOT NUMBER C1553848 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT 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 C1553848. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿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.¿ THE JAPANESE PACKAGING INSERT SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF (B)(4) WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. IMAGE REVIEW ¿ N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE USE OF A NON-RECOMMENDED WIRE GUIDE WITH THE DEVICE. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT A 0.014¿ WIRE GUIDE WAS USED WITH THE DEVICE AND THAT THE BIFURCATION ANGLE WAS TIGHT. IT IS POSSIBLE THAT THE USE OF A NON-RECOMMENDED WIRE GUIDE CAUSED AND/OR CONTRIBUTED TO INSUFFICIENT DEVICE SUPPORT DURING ADVANCEMENT AND/OR DEPLOYMENT. THIS INSUFFICIENT SUPPORT COMBINED WITH A TIGHT BIFURCATION ANGLE MAY HAVE RESULTED IN HIGH DEPLOYMENT FORCES ON THE OUTER SHEATH RESULTING IN DIFFICULTY DURING DEPLOYMENT AND STENT ELONGATION. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 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.
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)(6). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THE INTENDED USE OF THE COMPLAINT DEVICE WAS FOR EVT. THE APPROACH WAS GAINED FROM THE LEFT FEMORAL ARTERY. THE ANGLE OF THE ILIAC BIFURCATION WAS VERY TIGHT. THE WIRE GUIDE USED FOR THE COMPLAINT DEVICE WAS COMMAND PRODUCED BY CENTURY MEDICAL, INC (0.014 INCH). WHEN THE PHYSICIAN WAS DEPLOYING THE COMPLAINT STENT, IT BECAME UNABLE TO BE DEPLOYED HALFWAY. THEN, THE PHYSICIAN WITHDREW THE DEVICE A LITTLE FORCIBLY, AND THE STENT WAS PLACED WITH THE ELONGATED SHAPE. AS A RESULT, THE USER MANAGED TO DEPLOY THE STENT. AFTER THAT, BAIL-OUT STENTING WITH OTHER PTX S (7MM 12CM) WAS CONDUCTED ON THE COMPLAINT DEVICE. A WIRE GUIDE USED FOR BAIL-OUT STENTING WAS RADIFOCUS PRODUCED BY TERUMO (0.035INCH AND 300CM). BAIL-OUT STENTING WAS COMPLETED WITH 3PTX. ALSO, THE PROCEDURE WAS FINISHED, AND THE PATIENT EXPERIENCED NO ADVERSE EFFECTS.
THE INTENDED USE OF THE COMPLAINT DEVICE WAS FOR EVT. THE APPROACH WAS GAINED FROM THE LEFT FEMORAL ARTERY. THE ANGLE OF THE ILIAC BIFURCATION WAS VERY TIGHT. THE WIRE GUIDE USED FOR THE COMPLAINT DEVICE WAS COMMAND PRODUCED BY CENTURY MEDICAL, INC (0.014 INCH). WHEN THE PHYSICIAN WAS DEPLOYING THE COMPLAINT STENT, IT BECAME UNABLE TO BE DEPLOYED HALFWAY. THEN, THE PHYSICIAN WITHDREW THE DEVICE A LITTLE FORCIBLY, AND THE STENT WAS PLACED WITH THE ELONGATED SHAPE. AS A RESULT, THE USER MANAGED TO DEPLOY THE STENT. AFTER THAT, BAIL-OUT STENTING WITH OTHER PTX S (7MM 12CM) WAS CONDUCTED ON THE COMPLAINT DEVICE. A WIRE GUIDE USED FOR BAIL-OUT STENTING WAS RADIFOCUS PRODUCED BY TERUMO (0.035INCH AND 300CM). BAIL-OUT STENTING WAS COMPLETED WITH 3PTX. ALSO, THE PROCEDURE WAS FINISHED, AND THE PATIENT EXPERIENCED NO ADVERSE EFFECTS.
THE INTENDED USE OF THE COMPLAINT DEVICE WAS FOR EVT. THE APPROACH WAS GAINED FROM THE LEFT FEMORAL ARTERY. THE ANGLE OF THE ILIAC BIFURCATION WAS VERY TIGHT. THE WIRE GUIDE USED FOR THE COMPLAINT DEVICE WAS COMMAND PRODUCED BY CENTURY MEDICAL, INC (0.014 INCH). WHEN THE PHYSICIAN WAS DEPLOYING THE COMPLAINT STENT, IT BECAME UNABLE TO BE DEPLOYED HALFWAY. THEN, THE PHYSICIAN WITHDREW THE DEVICE A LITTLE FORCIBLY, AND THE STENT WAS PLACED WITH THE ELONGATED SHAPE. AS A RESULT, THE USER MANAGED TO DEPLOY THE STENT. AFTER THAT, BAIL-OUT STENTING WITH OTHER PTX S (7MM 12CM) WAS CONDUCTED ON THE COMPLAINT DEVICE. A WIRE GUIDE USED FOR BAIL-OUT STENTING WAS RADIFOCUS PRODUCED BY TERUMO (0.035INCH AND 300CM). BAIL-OUT STENTING WAS COMPLETED WITH 3PTX. ALSO, THE PROCEDURE WAS FINISHED, AND THE PATIENT EXPERIENCED NO ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 580648 | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | C1553848 | 10827002352855 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |