ZILVER SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2019-00547
- Event Type
- Injury
- Date Received
- October 16, 2019
- Report Date
- December 12, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
PMA/510(K) # P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K)#: P050017/S002 AND S003. THIS FOLLOW UP MDR IS BEING SUBMITTED AS A CANCELLATION REPORT, BASED ON CLINICAL INPUT RECEIVED IT HAS BEEN CONFIRMED THAT TARGET VESSEL REVASCULARISATION IS NOT DEVICE RELATED. 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. DEVICE EVALUATION: THE UNKNOWN ZILVER BMS 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. FOR THE PURPOSE OF THIS INVESTIGATION THE UNKNOWN BMS DEVICE HAS BEEN TAKEN TO BE A ZIV[5/6] DEVICE. 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 ZIV 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 RESTENOSIS OF THE STENTED ARTERY IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE INSTRUCTIONS FOR USE (IFU0043-9). THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED 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. IT SHOULD ALSO BE NOTED THAT RESTENOSIS IS A COMMON ADVERSE EVENT OF ENDOVASCULAR PROCEDURES AND IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE IFU. RESTENOSIS CAN BE CAUSED BY INJURY TO THE VESSEL (E.G. DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND/OR STENTING). VESSEL INJURY PROVOKES AN INFLAMMATORY RESPONSE THAT LEADS TO (OR AMPLIFIES) THE RESTENOSIS PROCESS. HOWEVER, IT HAS BEEN CONFIRMED THAT TARGET VESSEL REVASCULARISATION IS NOT DEVICE RELATED. THE COMPLAINT IS NOT CONFIRMED AS TVR IS NOT DEVICE RELATED. ACCORDING TO THE INITIAL REPORTER, TARGET VESSEL REVASCULARIZATION WAS REQUIRED AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) # P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
(B)(4). 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. IN THE UNMATCHED COHORT, THE ZILVER PTX PROCEDURES DID NOT SIGNIFICANTLY DIFFER IN TLR (TARGET LESION REVASCULARIZATION) AND TVR (TARGET-VESSEL REVASCULARIZATION) RATES AT 1 YEAR FROM BMS PROCEDURES (TLR: 9.2% VS 13.8% [P=.10]; TVR: 9.8% VS 13.8% [P=.16]). IN THE PROPENSITY-SCORE MATCHED DATA, ZILVER PTX PROCEDURES HAD SIGNIFICANTLY LOWER TLR AND TVR RATES COMPARED TO BMS PROCEDURES (TLR: 9.2% VS 18.4% [P=.01]; TVR: 9.8% VS 18.4% [P=.02]). THIS FILE IS BEING OPENED TO ADDRESS TARGET VESSEL REVASCULARIZATION (TVR) RATES AT 1 YEAR FROM BMS PROCEDURES WAS 13.8% FOR UNMATCHED COHORT METHOD & 18.4% FOR THE PROPENSITY-SCORE MATCHED DATA METHOD.
THIS REPORT IS BEING SUBMITTED AS A CANCELLATION MDR REPORT. (B)(4). 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. IN THE UNMATCHED COHORT, THE ZILVER PTX PROCEDURES DID NOT SIGNIFICANTLY DIFFER IN TLR (TARGET LESION REVASCULARIZATION) AND TVR (TARGET-VESSEL REVASCULARIZATION) RATES AT 1 YEAR FROM BMS PROCEDURES (TLR: 9.2% VS 13.8% [P=.10]; TVR: 9.8% VS 13.8% [P=.16]). IN THE PROPENSITY-SCORE MATCHED DATA, ZILVER PTX PROCEDURES HAD SIGNIFICANTLY LOWER TLR AND TVR RATES COMPARED TO BMS PROCEDURES (TLR: 9.2% VS 18.4% [P=.01]; TVR: 9.8% VS 18.4% [P=.02]). THIS FILE IS BEING OPENED TO ADDRESS TARGET VESSEL REVASCULARIZATION (TVR) RATES AT 1 YEAR FROM BMS PROCEDURES WAS 13.8% FOR UNMATCHED COHORT METHOD & 18.4% FOR THE PROPENSITY-SCORE MATCHED DATA METHOD.
(B)(6). 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. IN THE UNMATCHED COHORT, THE ZILVER PTX PROCEDURES DID NOT SIGNIFICANTLY DIFFER IN TLR (TARGET LESION REVASCULARIZATION) AND TVR (TARGET-VESSEL REVASCULARIZATION) RATES AT 1 YEAR FROM BMS PROCEDURES (TLR: 9.2% VS 13.8% [P=.10]; TVR: 9.8% VS 13.8% [P=.16]). IN THE PROPENSITY-SCORE MATCHED DATA, ZILVER PTX PROCEDURES HAD SIGNIFICANTLY LOWER TLR AND TVR RATES COMPARED TO BMS PROCEDURES (TLR: 9.2% VS 18.4% [P=.01]; TVR: 9.8% VS 18.4% [P=.02]). THIS FILE IS BEING OPENED TO ADDRESS TARGET VESSEL REVASCULARIZATION (TVR) RATES AT 1 YEAR FROM BMS PROCEDURES WAS 13.8% FOR UNMATCHED COHORT METHOD & 18.4% FOR THE PROPENSITY-SCORE MATCHED DATA METHOD.
PMA/510(K) # P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
(B)(6). 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. IN THE UNMATCHED COHORT, THE ZILVER PTX PROCEDURES DID NOT SIGNIFICANTLY DIFFER IN TLR (TARGET LESION REVASCULARIZATION) AND TVR (TARGET-VESSEL REVASCULARIZATION) RATES AT 1 YEAR FROM BMS PROCEDURES (TLR: 9.2% VS 13.8% [P=.10]; TVR: 9.8% VS 13.8% [P=.16]). IN THE PROPENSITY-SCORE MATCHED DATA, ZILVER PTX PROCEDURES HAD SIGNIFICANTLY LOWER TLR AND TVR RATES COMPARED TO BMS PROCEDURES (TLR: 9.2% VS 18.4% [P=.01]; TVR: 9.8% VS 18.4% [P=.02]). THIS FILE IS BEING OPENED TO ADDRESS TARGET VESSEL REVASCULARIZATION (TVR) RATES AT 1 YEAR FROM BMS PROCEDURES WAS 13.8% FOR UNMATCHED COHORT METHOD & 18.4% FOR THE PROPENSITY-SCORE MATCHED DATA METHOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 993000 | ZILVER SELF-EXPANDING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |