ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2019-00038
- Event Type
- Malfunction
- Date Received
- February 4, 2019
- Date of Event
- January 2, 2019
- Report Date
- March 4, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002384832
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
PMA/510(K) # = P100022/S026. 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/S026. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031 INFORMATION PERTAINING (B)(4). 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.
PMA/510(K) # = P100022/S026. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031 INFORMATION PERTAINING TO MFR AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: THE ZISV6-35-125-6-140-PTX DEVICE OF LOT NUMBER C1550389 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. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 31ST OF JANUARY 2019 AND WAS RE-EVALUATED ON THE 14TH MARCH 2019. THE DEVICE WAS RETURNED WITH THE WIRE GUIDE FROM THE PROCEDURE STUCK INSIDE. THE WIRE GUIDE HAD TO BE REMOVED WITH FORCE DURING THE LAB EVALUATION. A 0.035¿ WIRE GUIDE WAS ADVANCED THROUGH THE DISTAL INNER AND BECAME STUCK DUE TO CONGEALED BLOOD IN THE DEVICE. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZISV6-35-125-6-140-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 ZISV6-35-125-6-140-PTX OF LOT NUMBER C1550389 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 C1550389. IFU REVIEW: THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0118-4). IMAGE REVIEW: N/A. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO CONGEALED BLOOD IN THE DELIVERY SYSTEM. IT IS POSSIBLE THAT THE CONGEALED BLOOD CAUSED AND/OR CONTRIBUTED TO THE WIRE GUIDE BECOMING BOUND TO THE DELIVERY SYSTEM DURING THE PROCEDURE RESULTING IN DIFFICULTY REMOVING THE DEVICE. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. 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.
AT MY FACILITY IN (B)(6) A ZPTX CATHETER BECAME STUCK ON A MERIT MEDICAL LAUREATE WIRE. THE ENTIRE SYSTEM HAD TO BE RETRIEVED AFTER DEPLOYMENT. A TERUMO GLIDEWIRE WAS USED AS A RAIL FOR THE SECOND STENT THAT WAS DEPLOYED. TO MY KNOWLEDGE THERE WERE NO ADVERSE EVENTS THAT OCCURRED AS A RESULT OF THIS INCIDENT.
AT MY FACILITY IN HARLINGEN, TEXAS A ZPTX CATHETER BECAME STUCK ON A MERIT MEDICAL LAUREATE WIRE. THE ENTIRE SYSTEM HAD TO BE RETRIEVED AFTER DEPLOYMENT. A TERUMO GLIDEWIRE WAS USED AS A RAIL FOR THE SECOND STENT THAT WAS DEPLOYED. TO MY KNOWLEDGE THERE WERE NO ADVERSE EVENTS THAT OCCURRED AS A RESULT OF THIS INCIDENT.
AT MY FACILITY IN (B)(6) A ZPTX CATHETER BECAME STUCK ON A MERIT MEDICAL LAUREATE WIRE. THE ENTIRE SYSTEM HAD TO BE RETRIEVED AFTER DEPLOYMENT. A TERUMO GLIDEWIRE WAS USED AS A RAIL FOR THE SECOND STENT THAT WAS DEPLOYED. TO MY KNOWLEDGE THERE WERE NO ADVERSE EVENTS THAT OCCURRED AS A RESULT OF THIS INCIDENT. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. ALSO REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF"DELIVERY SYSTEM CANNOT BE WITHDRAWN". NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96382 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | G38483 | C1550389 | 10827002384832 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |