Literature was reviewed regarding the impact of gender on transcatheter aortic valve replacement outcomes. the study population included 927 patients who were predominantly male with a mean age of 83 years. multiple manufacturer¿s devices were implanted in the study population; an undisclosed number of patients were implanted with a medtronic corevalve, evolut r, or evolut pro bioprosthetic valve. deaths occurred in the study population; however, there was no statement establishing a causal or contributory relationship between medtronic product and the deaths. among all patients adverse events included: cardiac arrest, myocardial infarction, stroke, major vascular complication, and arrhythmia requiring permanent pacemaker implant. no further information was provided pertaining to medtronic products.
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Citation: see et al.Impact of sex on transcatheter aortic valve replacement outcomes: results of a single-center study.Int j cardiol.2024 mar 1:398:131643.Doi: 10.1016/j.Ijcard.2023.131643.Epub 2023 dec 6.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
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