Model Number EVOLUTR-29-US |
Device Problems
Fluid/Blood Leak (1250); Central Regurgitation (4068)
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Patient Problem
Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 03/14/2024 |
Event Type
Injury
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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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Medtronic received information that approximately seven years and three months following the implant of this transcatheter bioprosthetic valve in a patient with a previous surgical aortic valve replacement, the patient experienced shortness of breath, and aortic insufficiency was identified.Subsequently, a second transcatheter aortic valve replacement was performed.No additional adverse patient effects were reported.
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Event Description
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Additional information was received that aortic insufficiency was severe central regurgitation.
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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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Search Alerts/Recalls
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