ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2019-00537
- Event Type
- Death
- Date Received
- October 16, 2019
- Report Date
- December 11, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- PMA / PMN Number
- P100022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
PMA/510(K) #: P100022. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. LITERATURE REPORTED EVENT - CONTACT DETAILS UNKNOWN. - ATTACHMENT: [2018 - JEON-SLAUGHTER OCT 2018 JIC WM.PDF].
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. LITERATURE REPORTED EVENT - CONTACT DETAILS UNKNOWN. - ATTACHMENT: [2018 - JEON-SLAUGHTER OCT 2018 JIC WM.PDF]
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 ZISV6 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. 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 ZISV6 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 (IFU0118-5). THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE IFU. 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 02 CARDIOVASCULAR EVENTS AND 03 UNDETERMINED CAUSES. THE DIRECTOR OF REGULATORY SCIENCE PI (PAD) WAS CONTACTED FOR INPUT REGARDING THE UNKNOWN DEATH EVENTS. HE CONFIRMED THAT ALL OF THE DEATH EVENTS WERE ADJUDICATED BY A CLINICAL EVENTS COMMITTEE AND NONE OF THE DEATH EVENTS WERE REPORTED AS BEING DEVICE RELATED. IT IS POSSIBLE THAT THE UNKNOWN DEATH EVENTS RELATED TO PATIENT PRE-EXISTING CONDITIONS. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE PATIENT PRE-EXISTING CONDITIONS INCLUDED SMOKING, TYPE I AND TYPE II DIABETES, HYPERLIPIDAEMIA, HYPERTENSION, CORONARY ARTERY DISEASE (CAD), MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE AND RENAL INSUFFICIENCY. SUMMARY THE COMPLAINT IS NOT CONFIRMED AS THE EVENT IS NOT CONSIDERED TO BE DEVICE RELATED. ACCORDING TO THE INITIAL REPORTER, 02 CARDIOVASCULAR RELATED DEATH OCCURRED AND 03 DEATH OCCURRED FOR REASONS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
FOLLOW UP REPORT IS TO INFORM THE FDA THE INVESTIGATION IS STILL PENDING. 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. THE 1-YEAR DEATH EVENTS IN THE ZILVER PTX GROUP INCLUDED 2 CARDIOVASCULAR AND 3 ADDITIONAL UNDETERMINED CAUSES OF DEATH. 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. 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 ZILVER PTX (2 CARDIOVASCULAR AND 3 ADDITIONAL UNDETERMINED CAUSES OF DEATH).
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. THE 1-YEAR DEATH EVENTS IN THE ZILVER PTX GROUP INCLUDED 2 CARDIOVASCULAR AND 3 ADDITIONAL UNDETERMINED CAUSES OF DEATH. 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. 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 ZILVER PTX (2 CARDIOVASCULAR AND 3 ADDITIONAL UNDETERMINED CAUSES OF DEATH)
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. THE 1-YEAR DEATH EVENTS IN THE ZILVER PTX GROUP INCLUDED 2 CARDIOVASCULAR AND 3 ADDITIONAL UNDETERMINED CAUSES OF DEATH. 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. 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 ZILVER PTX (2 CARDIOVASCULAR AND 3 ADDITIONAL UNDETERMINED CAUSES OF DEATH).
PMA/510(K) #: P100022. 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. THE 1-YEAR DEATH EVENTS IN THE ZILVER PTX GROUP INCLUDED 2 CARDIOVASCULAR AND 3 ADDITIONAL UNDETERMINED CAUSES OF DEATH. 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. 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 ZILVER PTX (2 CARDIOVASCULAR AND 3 ADDITIONAL UNDETERMINED CAUSES OF DEATH).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 990786 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |