ZILVER VASCULAR SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2019-00533
- Event Type
- Death
- Date Received
- October 16, 2019
- Report Date
- December 11, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
PMA/510(K) #: P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. LITERATURE REPORTED EVENT - CONTACT DETAILS UNKNOWN.
PMA/510(K) #: P050017/S002 AND S003. THIS FOLLOW UP MDR IS BEING SUBMITTED AS A CANCELLATION REPORT, BASED ON INPUT RECEIVED FROM THE DIRECTOR OF REGULATORY SCIENCE PI (PAD) THERE IS NO EVIDENCE TO SUGGEST ANY OF THESE DEATHS ARE POTENTIALLY RELATED TO THE ZILVER PTX STENT. THIS EVENT HAS BEEN RE-ASSESSED AND THIS REPORT IS TO NOTIFY THE FDA THAT THIS EVENT NO LONGER MEETS THE FDA REPORTING CRITERIA OF A MALFUNCTION OR SERIOUS INJURY REPORT AS PER SECTION 803.50 OF 21 CFR 803. LITERATURE REPORTED EVENT - CONTACT DETAILS UNKNOWN. DEVICE EVALUATION THE ZFV6 DEVICE OF UNKNOWN LOT NUMBER 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. IT SHOULD BE NOTED THAT THE RPN OF THE BMS DEVICE WAS NOT DISCLOSED IN THE ARTICLE. AS THE STENT WAS USED FOR TREATMENT IN THE FEMOROPOPLITEAL ARTERIES THIS FILE HAS BEEN ASSESSED AS A ZILVER FLEX (ZFV6) STENT. DOCUMENT REVIEW AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ZFV6 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. IT SHOULD BE NOTED THAT DEATH IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE INSTRUCTIONS FOR USE. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE IFU (IFU0058-4). ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE 1-YEAR DEATH EVENTS INCLUDED 01 CARDIOVASCULAR EVENT AND 01 UNKNOWN EVENT. THE DIRECTOR OF REGULATORY SCIENCE PI (PAD) WAS CONTACTED FOR INPUT REGARDING THE UNKNOWN DEATH EVENT. HE CONFIRMED THAT THE AUTHORS DO NOT MENTION THAT THE DEATH EVENTS WERE DEVICE RELATED. IT SHOULD BE NOTED THAT THE AUTHORS MENTION THAT THE RATES OF DEATH (AMONGST OTHER EVENTS) WERE SIMILAR TO PREVIOUS STUDIES CONDUCTED. IT IS POSSIBLE THAT THE UNKNOWN DEATH EVENT RELATED TO PATIENT PRE-EXISTING CONDITIONS. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT PATIENT PRE-EXISTING CONDITIONS INCLUDED CRITICAL LIMB ISCHEMIA, CHRONIC KIDNEY DISEASE, DIABETES MELLITUS, HYPERTENSION, HEAVY CALCIFICATION, IN-STENT RESTENOSIS (ISR) AND SMOKING. IT IS POSSIBLE THAT THE PRE-EXISTING CONDITIONS CONTRIBUTED TO THE EVENT OF RESTENOSIS. SUMMARY THE COMPLAINT IS NOT CONFIRMED AS THE EVENT IS NOT CONSIDERED TO BE DEVICE RELATED. ACCORDING TO THE INITIAL REPORTER, 01 CARDIOVASCULAR RELATED DEATH OCCURRED AND 01 DEATH OCCURRED FOR REASONS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. LITERATURE REPORTED EVENT - CONTACT DETAILS UNKNOWN. - [2018 - JEON-SLAUGHTER OCT 2018 JIC WM.PDF].
THIS STUDY CONDUCTED A COMPARATIVE EFFECTIVENESS ANALYSIS OF ZILVER PTX AND CONTEMPORARY BMS FOR FEMOROPOPLITEAL ARTERY ENDOVASCULAR INTERVENTION USING THE MULTICENTER EXCELLENCE IN PERIPHERAL ARTERY DISEASE (XLPAD). THIS STUDY COMPARED CLINICALLY DRIVEN 1-YEAR TARGET-LESION REVASCULARIZATION (TLR), TARGET-VESSEL REVASCULARIZATION (TVR), AND TARGET-LIMB REVASCULARIZATION RATES BETWEEN ZILVER PTX STENT AND BMS TREATMENTS IN FEMOROPOPLITEAL DISTRIBUTION. THEY ALSO COMPARED 1-YEAR ALL-CAUSE MORTALITY IN THE RESPECTIVE TREATMENT GROUPS. THE STUDY EXTRACTED DATA FROM THE AVAILABLE 969 XLPAD REGISTRY PATIENTS WHO UNDERWENT FEMOROPOPLITEAL STENT INTERVENTIONS (UNMATCHED DATA) BETWEEN (B)(6) 2013 AND (B)(6) 2016 AT ELEVEN XLPAD PARTICIPATING SITES IN THE UNITED STATES. ONE-YEAR ALL-CAUSE MORTALITY AND THREE REVASCULARIZATION OUTCOMES ¿ CLINICALLY DRIVEN TLR, TVR, AND TARGET-LIMB REVASCULARIZATION ¿ WERE INCLUDED IN THE ANALYSIS. 174 ZILVER PTXS AND 174 BMSS WERE USED IN THIS STUDY. THE BMS GROUP CONTAINED 53 ZILVER BARE METAL STENTS. THIS FILE WAS CREATED TO CAPTURE 1-YEAR DEATH EVENTS IN THE MATCHED BMS GROUP INCLUDED 1 CARDIOVASCULAR AND 1 UNKNOWN EVENT. THE ZILVER PTX GROUP HAD A SIGNIFICANTLY HIGHER ALL-CAUSE MORTALITY RATE THAN THE BMS GROUP. ALL CARDIOVASCULAR DEATHS HAPPENED BETWEEN 58 AND 84 DAYS POST PROCEDURE. IT IS UNKNOWN IF THE PATIENT DEATH'S ON BARE METAL STENT'S WERE ZILVER DEVICE'S THEREFORE WE WILL CONSERVATIVELY ASSESS DUE TO POTENTIAL. 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 BASED ON 2 PATIENT DEATH'S REPORTED ON BARE METAL STENT'S (1 CARDIOVASCULAR AND 1 UNKNOWN EVENT).
THIS REPORT IS BEING SUBMITTED AS A CANCELLATION MDR REPORT. THIS STUDY CONDUCTED A COMPARATIVE EFFECTIVENESS ANALYSIS OF ZILVER PTX AND CONTEMPORARY BMS FOR FEMOROPOPLITEAL ARTERY ENDOVASCULAR INTERVENTION USING THE MULTICENTER EXCELLENCE IN PERIPHERAL ARTERY DISEASE (XLPAD) THIS STUDY COMPARED CLINICALLY DRIVEN 1-YEAR TARGET-LESION REVASCULARIZATION (TLR), TARGET-VESSEL REVASCULARIZATION (TVR), AND TARGET-LIMB REVASCULARIZATION RATES BETWEEN ZILVER PTX STENT AND BMS TREATMENTS IN FEMOROPOPLITEAL DISTRIBUTION. THEY ALSO COMPARED 1-YEAR ALL-CAUSE MORTALITY IN THE RESPECTIVE TREATMENT GROUPS. THE STUDY EXTRACTED DATA FROM THE AVAILABLE 969 XLPAD REGISTRY PATIENTS WHO UNDERWENT FEMOROPOPLITEAL STENT INTERVENTIONS (UNMATCHED DATA) BETWEEN (B)(6) 2013 AND (B)(6) 2016 AT ELEVEN XLPAD PARTICIPATING SITES IN THE UNITED STATES. ONE-YEAR ALL-CAUSE MORTALITY AND THREE REVASCULARIZATION OUTCOMES ¿ CLINICALLY DRIVEN TLR, TVR, AND TARGET-LIMB REVASCULARIZATION ¿ WERE INCLUDED IN THE ANALYSIS. 174 ZILVER PTXS AND 174 BMSS WERE USED IN THIS STUDY. THE BMS GROUP CONTAINED 53 ZILVER BARE METAL STENTS. THIS FILE WAS CREATED TO CAPTURE 1-YEAR DEATH EVENTS IN THE MATCHED BMS GROUP INCLUDED 1 CARDIOVASCULAR AND 1 UNKNOWN EVENT. THE ZILVER PTX GROUP HAD A SIGNIFICANTLY HIGHER ALL-CAUSE MORTALITY RATE THAN THE BMS GROUP. ALL CARDIOVASCULAR DEATHS HAPPENED BETWEEN 58 AND 84 DAYS POST PROCEDURE. IT IS UNKNOWN IF THE PATIENT DEATH'S ON BARE METAL STENT'S WERE ZILVER DEVICE'S THEREFORE WE WILL CONSERVATIVELY ASSESS DUE TO POTENTIAL.
THIS STUDY CONDUCTED A COMPARATIVE EFFECTIVENESS ANALYSIS OF ZILVER PTX AND CONTEMPORARY BMS FOR FEMOROPOPLITEAL ARTERY ENDOVASCULAR INTERVENTION USING THE MULTICENTER EXCELLENCE IN PERIPHERAL ARTERY DISEASE (XLPAD). THIS STUDY COMPARED CLINICALLY DRIVEN 1-YEAR TARGET-LESION REVASCULARIZATION (TLR), TARGET-VESSEL REVASCULARIZATION (TVR), AND TARGET-LIMB REVASCULARIZATION RATES BETWEEN ZILVER PTX STENT AND BMS TREATMENTS IN FEMOROPOPLITEAL DISTRIBUTION. THEY ALSO COMPARED 1-YEAR ALL-CAUSE MORTALITY IN THE RESPECTIVE TREATMENT GROUPS. THE STUDY EXTRACTED DATA FROM THE AVAILABLE 969 XLPAD REGISTRY PATIENTS WHO UNDERWENT FEMOROPOPLITEAL STENT INTERVENTIONS (UNMATCHED DATA) BETWEEN OCTOBER 2013 AND DECEMBER 2016 AT ELEVEN XLPAD PARTICIPATING SITES IN THE UNITED STATES. ONE-YEAR ALL-CAUSE MORTALITY AND THREE REVASCULARIZATION OUTCOMES ¿ CLINICALLY DRIVEN TLR, TVR, AND TARGET-LIMB REVASCULARIZATION ¿ WERE INCLUDED IN THE ANALYSIS. 174 ZILVER PTXS AND 174 BMSS WERE USED IN THIS STUDY. THE BMS GROUP CONTAINED 53 ZILVER BARE METAL STENTS. THIS FILE WAS CREATED TO CAPTURE 1-YEAR DEATH EVENTS IN THE MATCHED BMS GROUP INCLUDED 1 CARDIOVASCULAR AND 1 UNKNOWN EVENT. THE ZILVER PTX GROUP HAD A SIGNIFICANTLY HIGHER ALL-CAUSE MORTALITY RATE THAN THE BMS GROUP. ALL CARDIOVASCULAR DEATHS HAPPENED BETWEEN 58 AND 84 DAYS POST PROCEDURE. IT IS UNKNOWN IF THE PATIENT DEATH'S ON BARE METAL STENT'S WERE ZILVER DEVICE'S THEREFORE WE WILL CONSERVATIVELY ASSESS DUE TO POTENTIAL. 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 BASED ON 2 PATIENT DEATH'S REPORTED ON BARE METAL STENT'S (1 CARDIOVASCULAR AND 1 UNKNOWN EVENT).
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
THIS STUDY CONDUCTED A COMPARATIVE EFFECTIVENESS ANALYSIS OF ZILVER PTX AND CONTEMPORARY BMS FOR FEMOROPOPLITEAL ARTERY ENDOVASCULAR INTERVENTION USING THE MULTICENTER EXCELLENCE IN PERIPHERAL ARTERY DISEASE (XLPAD). THIS STUDY COMPARED CLINICALLY DRIVEN 1-YEAR TARGET-LESION REVASCULARIZATION (TLR), TARGET-VESSEL REVASCULARIZATION (TVR), AND TARGET-LIMB REVASCULARIZATION RATES BETWEEN ZILVER PTX STENT AND BMS TREATMENTS IN FEMOROPOPLITEAL DISTRIBUTION. THEY ALSO COMPARED 1-YEAR ALL-CAUSE MORTALITY IN THE RESPECTIVE TREATMENT GROUPS. THE STUDY EXTRACTED DATA FROM THE AVAILABLE 969 XLPAD REGISTRY PATIENTS WHO UNDERWENT FEMOROPOPLITEAL STENT INTERVENTIONS (UNMATCHED DATA) BETWEEN OCTOBER 2013 AND DECEMBER 2016 AT ELEVEN XLPAD PARTICIPATING SITES IN THE UNITED STATES. ONE-YEAR ALL-CAUSE MORTALITY AND THREE REVASCULARIZATION OUTCOMES CLINICALLY DRIVEN TLR, TVR, AND TARGET-LIMB REVASCULARIZATION WERE INCLUDED IN THE ANALYSIS. 174 ZILVER PTXS AND 174 BMSS WERE USED IN THIS STUDY. THE BMS GROUP CONTAINED 53 ZILVER BARE METAL STENTS. THIS FILE WAS CREATED TO CAPTURE 1-YEAR DEATH EVENTS IN THE MATCHED BMS GROUP INCLUDED 1 CARDIOVASCULAR AND 1 UNKNOWN EVENT. THE ZILVER PTX GROUP HAD A SIGNIFICANTLY HIGHER ALL-CAUSE MORTALITY RATE THAN THE BMS GROUP. ALL CARDIOVASCULAR DEATHS HAPPENED BETWEEN 58 AND 84 DAYS POST PROCEDURE. IT IS UNKNOWN IF THE PATIENT DEATH'S ON BARE METAL STENT'S WERE ZILVER DEVICE'S THEREFORE WE WILL CONSERVATIVELY ASSESS DUE TO POTENTIAL. 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 BASED ON 2 PATIENT DEATH'S REPORTED ON BARE METAL STENT'S (1 CARDIOVASCULAR AND 1 UNKNOWN EVENT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 991330 | ZILVER VASCULAR SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |