Model Number EVOLUTPRO-29-US |
Device Problems
Fluid/Blood Leak (1250); Device Stenosis (4066); Central Regurgitation (4068)
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Patient Problems
Aortic Valve Stenosis (1717); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 03/04/2024 |
Event Type
Injury
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Event Description
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Medtronic received information that 6 years 2 months following the implant of this transcatheter bioprosthetic valve, computed tomography (ct) revealed aortic stenosis with mild to moderate aortic insufficiency was observed.The patient is being evaluated for possible transcatheter aortic valve (tav) in tav but no treatment has been performed.No additional adverse patient effects were reported.
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Manufacturer Narrative
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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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Manufacturer Narrative
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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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Event Description
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Additional information was received that the aortic insufficiency was central aortic regurgitation.
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Search Alerts/Recalls
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