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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Myocardial Infarction (1969); Occlusion (1984); Thrombosis/Thrombus (4440)
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Event Date 03/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Journal article, 'device profile of the resolute onyx zotarolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy'; authors: moritz blum, davide cao, roxana mehran journal: 'expert review of medical devices', year: 2020; reference: doi:10.1080/17434440.2020.1736037 there is no established or suspected causal relationship between the device and the death events.Deaths are common occurrences in clinical studies, however, the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.
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Event Description
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An article titled, 'device profile of the resolute onyx zota rolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy', was submitted.The aim of the article was to review the resolute onyx device features using pre-clinical evidence and clinical studies which involved patient's being treated with resolute onyx.The review used data from several studies and registries including the bionix trial, onyx one trial, resolute onyx 2mm clinical study, hong kong resolute onyx registry, resolute onyx core trial and the kamir registry.The total of 3076 participants from these studies that had at least one resolute onyx implanted.Clinical outcomes included target lesion failure (tlf); defined as a composite of cardiac death, target vessel mi and target lesion revascularization (tlr); definite and probable stent thrombosis, late lumen loss, chronic total occlusion and in-stent restenosis.Malposed struts at baseline and 30 days were also reported, with no stent recoil or significant late acquired malposition indicated.The article also referred to two studies in which resolute integrity coronary drug eluting stents were used, the dutch peers study and the sort out vi study.One year follow-up outcomes for these studies included cardiac death, myocardial infarction and target vessel revascularization (tvr).
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Search Alerts/Recalls
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