Model Number EVOLUTPRO-26-US |
Device Problems
Fluid/Blood Leak (1250); Perivalvular Leak (1457); Central Regurgitation (4068)
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Patient Problems
Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2024 |
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 six years and four months following the implant of this transcatheter bioprosthetic valve, the patient developed symptoms of heart failure.Subsequently, aortic regurgitation was identified.No additional adverse patient effects were reported.
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Event Description
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Additional information was received that the aortic regurgitation appeared to be both central and paravalvular leak (pvl).A non-medtronic valve was implanted.
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Manufacturer Narrative
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Updated a.3b updated b.5 updated h.6.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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