Kibrik 2019 ¿a real-world experience of drug eluting and non-drug eluting stents in lower extremity peripheral arterial disease¿ a retrospective review was performed on all in patient infrainguinal lower extremity endovascular procedures between january 2014 and september 2016, which involved stent implantation.Procedures involving the common femoral artery, superficial femoral artery, and above knee popliteal artery were included.Procedures involving iliac, below knee popliteal, tibial, peroneal, and pedal arteries were excluded.The type of stent, number of stents, length of each stent, and location of stent were recorded for each procedure.Data on each patients trans-atlantic inter society consensus ii class were collected.End-points included stent thrombosis, restenosis, re-intervention, and limb loss.Post-operative arterial duplexes were obtained every three months to determine stent patency during follow-up visits.In-stent stenosis was defined as >60% narrowing on arterial duplex.Thrombosis was defined as in-stent occlusion, and limb loss involved only major amputations in the treated extremity.Bivariate analysis and students two-sample t-test were used to analyze the data.Ibm-spss ¿ 22 was used for all analyses.This file was opened to capture re-stenosis 46% rate for des.46 procedures involved only des zilver (cook).
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Pma/510(k) #p100022/s027.Device evaluation.The unknown devices of unknown lot number involved in this complaint were implanted in the patients and were not available for evaluation.With the information provided, a document based investigation was conducted.Lab evaluation ¿ n/a.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 restenosis of the stented artery is listed as a known potential adverse event within the instructions for use (ifu0117-5).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/underlying conditions.From the literature article it is known that patient pre-existing conditions included coronary artery disease, hyperlipidaemia, atrial fibrillation , deep vein thrombosis critical limb threatening ischemia and diabetes.Restenosis of the stented artery is also listed as a known potential adverse event within the ifu and is a common adverse event of endovascular procedures that 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.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.Summary.Complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.
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