Medtronic received information that 8 years and 7 months post implant of this aortic mechanical valve (manufacturer unknown), the patient presented to the emergency department with exertional shortness of breath and chest pressure.He was admitted to the hospital for further management and diuresis.One day later, transesophageal echocardiogram (tee) revealed elevated gradients with an aorticvalve area of 0.6cm^2.One of the mechanical valve leaflets was mobile, but the other leaflet was "stuck in position".Prior to being able to administer medication, the patient had a pulseless electrical activity (pea) arrest.Advanced cardiovascular life support (acls) was provided, but the patient did not regain a perfusing rhythm and died.
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This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) related to capa pr 564122.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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