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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Myocardial Infarction (1969); Occlusion (1984); Thrombus (2101); Stenosis (2263); Injury (2348)
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Event Date 01/28/2019 |
Event Type
Injury
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Manufacturer Narrative
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Journal article: long-term clinical outcomes of isolated ostial left anterior descending disease treatment: ostial stenting versus left main cross-over stenting authors: gianluca rigatelli, marco zuin, enrico baracca, et.Al.Journal: cardiovascular revascularization medicine year: 2019 reference: https://doi.Org/10.1016/j.Carrev.2019.01.030.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.Date of publication procedural images provided in the article show a lesion treated by a resolute integrity stent and subocclusive in-stent restenosis treated by a non-medtronic device.There are no other images present that offer further information on the adverse events reported.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A journal article was submitted.The aim of the study was to compare the long term clinical outcomes of two stenting techniques, ostial stenting versus left main cross-over stenting, used in the treatment of isolated ostial left anterior descending disease.Resolute integrity and resolute onyx rx coronary drug eluting stents were among those implanted in the patients.Clinical outcomes reported in the study population included cardiac death, myocardial infarction, stroke, tvr (target vessel revascularisation), in-stent restenosis, stent thrombosis and abrupt vessel occlusion.
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Search Alerts/Recalls
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