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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Myocardial Infarction (1969); Thrombus (2101)
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Event Date 03/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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Title: coronary calcification and long-term outcomes according to drug-eluting stent generation authors: paul guedeney, bimmer e.Claessen, roxana mehran, et.Al.Journal: jacc: cardiovascular intervention issue: 12 ref: doi.Org/10.1016/j.Jcin.2020.03.053.Age=average age.Sex= majority gender.Ethnicity= majority race.Date of event=date of publication patient death(s) were also included in the results of the journal article, however no causal link suggesting that the medtronic device(s) used in the patient cohort may have caused or contributed to the death(s) was provided 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 "coronary calcification and long-term outcomes according to drug-eluting stent generation" was submitted.The aim of the study was to evaluate the long-term impact of coronary artery calcification (cac) on outcomes after percutaneous coronary intervention and the respective performance of first- and second-generation drug-eluting stents (des).This study was a large patient-level meta-analysis of 18 randomized trials comprising 19,833 patients treated with des.The patients were divided into two groups based on the type of stents they were treated with: first generation des and second generation des.The endeavor rx and resolute integrity rx were among the stents used to treat patients in the second generation des group.Second generation des were used in 11,960 patients.Clinical outcomes were assessed at 5 year follow up.Clinical outcomes included all-cause and cardiac death, myocardial infarction, any revascularization, target lesion revascularization (tlr), target lesion failure and probable or definite stent thrombosis.
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Search Alerts/Recalls
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