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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Medtronic received information that 14 years and 2 months post implant of this aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement.The reason for evaluation was not reported.No intervention or adverse patient effects were reported.Subsequently 3 days later, the patient had an aortic valve-in-valve replacement with a transcatheter valve from a different manufacturer.The reason for replacement was reported as moderate aortic stenosis (as) and moderate aortic regurgitation (ar).No additional adverse patient effects were reported.
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