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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Myocardial Infarction (1969); Stenosis (2263); Thrombosis/Thrombus (4440)
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Event Date 04/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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Journal article: outcomes of patients with coronary arterial bifurcation narrowings undergoing provisional 1-stent treatment (from the bionics trial) authors: maayan konigstein, david e.Kandzari, pieter c.Smits, et.Al.Journal: the american journal of cardiology year: 2020 reference: https://doi.Org/10.1016/j.Amjcard.2020.04.002.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 "outcomes of patients with coronary arterial bifurcation narrowings undergoing provisional 1-stent treatment (from the bionics trial)" was submitted.The aim of the study was evaluate the outcomes of patients with bifurcation lesions undergoing pci with the use of contemporary drug eluting stents, to analyze the impact of pre-procedural side branch stenosis and to evaluate the performance of the res compared with zes in the treatment of bifurcation lesions.Resolute integrity and resolute onyx coronary drug eluting stents were among the devices used in the pci procedures to treat both bifurcation and non-bifurcation lesions.Patients were followed up at 30 days,1 year and 2 years after the procedure.Clinical outcomes reported in the study population included death (cardiac and all cause deaths), myocardial infarction, target lesion revascularization (tlr), target vessel revascularization (tvr), restenosis and stent thrombosis.
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Search Alerts/Recalls
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