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From information provided, it is known that the patient underwent 2 interventions to treat occlusion.This pr addresses the 2nd intervention conducted on the (b)(6) 2016.The 1st intervention conducted on (b)(6) 2015 is addressed in report # 3001845648-2016-00212.2x ziv6-35-125-6-80-ptx stents of lot number c937507 were implanted in the patient and are therefore unavailable for evaluation.With the information provided a document based investigation was carried out.Images were provided to support the complaint investigation and were reviewed through cook research and the following comments were provided by the independent reviewer: ¿findings: implantation angiography, one year post-implantation ultrasound and x-rays,1.5 year post cta with runoff and secondary intervention angiography, two year post ultrasound and abi, and 2.5 year post repeat secondary intervention are provided along with the complaint report.The study lesion was a 6cm distal right sfa proximal popliteal artery occlusion.The lesion was eliminated with two overlapping ptx stents.By one year a severe focal proximal sfa stenosis was present on ultrasound while the stents were free of stenosis.By 1.5 years, the stents thrombosed on cta.Subsequent overnight lysis and angioplasty uncovered moderate in-stent stenoses in each study stent that was new since the one year ultrasound.These in-stent stenoses were consistent with neointimal hyperplasia.The proximal stent stenosis was located just proximal the overlap with the distal stent and in the expected location of the adductor canal.The distal stent stenosis was located at its training edge.After the proximal sfa stenosis was treated with angioplasty, a third stent, also likely a 120mm zilver ptx stent, was implanted across the proximal stenosis through the proximal study stent.At two year ultrasound, a severe stenosis, greater than 80%, developed in the new stent at the site of the proximal stenosis.Also, a greater than 50% from neointimal hyperplasia recurred in the proximal study stent.Subsequent angiography at 2.5 years demonstrated than the recurrent proximal study stent in stent stenosis was at the same location as before, just proximal the stent overlap.The in-stent stenosis from neointimal hyperplasia previously angioplastied in the distal stent did not recur.These two stenoses resolved after angioplasty.No inflow or runoff limitation was present.Two vessel runoff was provided by the anterior tibial and peroneal arteries.Impression: ln-stent stenosis from neo-intimal hyperplasia in both study stents was confirmed.The proximal stent developed moderate recurrent neointimal hyperplasia at the expected location of the adductor canal.The distal stent developed moderate neointimal hyperplasia at its trailing edge that resolved after the first secondary intervention.A severe proximal sfa stenosis developed during, the first year.This preceded and likely contributed to the development of study stent neointimal hyperplasia.Significant findings relative to the patient's anatomy were not observed.Significant findings relative to the disease state were observed.A severe stenosis developed in the sfa proximal the study stents during the first year.Significant findings relative to the use of the device were not observed.Significant findings relative to the design or performance of the device were observed.The study stents developed neointimal hyperplasia.The neointimal hyperplasia was likely exacerbated by the inflow limiting proximal sfa stenosis.Cause of adverse events was not observed.¿ engineering input was requested for similar complaints regarding the findings relative to the design/performance of the device and the following comments were received: ¿restenosis is caused by an exaggerated healing response to arterial injury as a result of mechanical damage from the angioplasty/stenting procedure.The potential cause of restenosis is not directly related to the design of the device and therefore cannot be reduced further by design.Arterial injury is an unavoidable outcome from the angioplasty/stenting procedure.Angioplasty alone can cause arterial injury leading to restenosis.Therefore restenosis caused by the angioplasty/stenting procedure poses no greater risk than angioplasty alone.In fact, our clinical study results indicate that the risk of restenosis when the zilver ptx stent is used is significantly lower than when angioplasty alone is performed, or when stenting with a bare zilver stent is performed.As determined by (risk/benefit analysis) rba0004 the clinical benefits of the zilver ptx drug-eluting stent system outweigh the risks to the patient.¿ the customer complaint can be confirmed as neointimal hyperplasia developed in zilver ptx stents.According to the imaging review, the proximal stent developed moderate recurrent neointimal hyperplasia at the expected location of the adductor canal.The distal stent developed moderate neointimal hyperplasia at its trailing edge that resolved after the first secondary intervention.A severe proximal sfa stenosis developed during the first year which preceded and likely contributed to the development of the study stent neointimal hyperplasia.It can be noted that a third stent was implanted during the second intervention on (b)(6) 2015.The stent, likely a 120mm zilver ptx stent, was implanted across the proximal stenosis, through the proximal stent.The rpn and lot number of this stent are unknown.At the 2 year ultrasound, a severe stenosis had developed in the new stent at the site of the proximal stenosis.A new pr will be opened to address the occlusion of the 120mm zilver ptx stent in this event.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response that leads to or amplifies the restenosis process.It may be noted that the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.Based on the above, it is very unlikely that the reported restenosis could have occurred due to zilver ptx malfunction; however a definitive cause of this event cannot be determined.It may be noted that as per the instructions for use restenosis of the stented artery is a known potential adverse event associated with the placement of this device.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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 c937507.According to the complaint information, treatment during the 3rd intervention included balloon angioplasty.No other adverse events were reported for the patient.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
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The lesion morphology of the study lesion in the right distal sfa and popliteal artery indicated a tasc i and tasc ii, type b lesion with mild calcification and no thrombus.The lesion was not pre-dilated.Two 6 x 80 mm study stents were deployed into the right distal sfa and popliteal artery.Post-stent dilatation was performed.On (b)(6) 2013 (day of the procedure), the post-procedure clinical assessment was completed.The patient continued to take clopidogrel and aspirin, however aspirin was discontinued later at an unknown date and restarted again on (b)(6) 2015.On (b)(6) 2014 (373 days post-procedure), the 12-month clinical follow-up and imaging were completed.Patency of the study lesion was assessed by ultrasound examination and revealed that the lesion was patent proximal to, within, and distal to the study lesion.The core lab analysis concurred with these findings.The x-ray revealed no study stent fractures and the core lab analysis concurred.The patient continued to take clopidogrel.Since the last contact, the patient had not had any significant medical problems or hospitalizations.On (b)(6) 2015 (595 days post-procedure), the patient was hospitalized and underwent intervention due to occlusion of the study lesion in the right distal sfa.Treatment included thrombolysis, balloon angioplasty, and stent placement (proximal to but overlapping the study stent).The study investigator indicated that the event was probably related to the study product and not related to the study procedure and responded no to the question: did the device malfunction or deteriorate in characteristics or performance? on (b)(6) 2016 (786 days post-procedure), the two year clinical follow-up and ultrasound were completed.Patency of the study lesion was assessed by ultrasound examination and revealed that the lesion was patent proximal to and distal to the study lesion, however there was 50 - 99 % stenosis within the study lesion the core lab analysis concurred with these findings.The patient continued to take clopidogrel.Abnormal abis performed on (b)(6) 2016 (877 days post-procedure) prompted further intervention due to occlusion of the study lesion within the distal sfa.The study investigator confirmed occlusion within the study stent and the non-study stent that was proximal to and overlapping the study stent).Treatment included balloon angioplasty.The study investigator indicated that the event was probably related to the study product and not related to the study procedure and responded no to the question: did the device malfunction or deteriorate in characteristics or performance? note two separate interventional events have been reported for 2 x ziv6-35-125-6-80-ptx devices of the same lot (c937507).A separate report has been submitted for each event.Reference also report # 3001845648-2016-00212.
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