MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTR-23 |
Device Problems
Perivalvular Leak (1457); Patient Device Interaction Problem (4001)
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Patient Problems
Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); Heart Block (4444); Valvular Insufficiency/ Regurgitation (4449)
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Event Date 02/12/2024 |
Event Type
Injury
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Manufacturer Narrative
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Citation: elnwagy et al.Impact of prosthesis oversizing on clinical outcomes of transcatheter aortic valve implantation using a sel f-expandable evolut r valve.Egypt heart j.2024 feb 12;76(1):20.Doi: 10.1186/s43044-024-00450-0.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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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Literature was reviewed regarding the impact of prosthesis oversizing on clinical outcomes of transcatheter aortic valve implantation. the study population included 143 patients with a mean age of 73.8 years, a mean weight of 73.80 kg, and who were predominantly male. all patients were implanted with a medtronic evolut r bioprosthetic valve. among all patients adverse events included: moderate paravalvular leak, complete heart block, atrial fibrillation, or other arrhythmia requiring permanent pacemaker implant. no further information was provided pertaining to medtronic products.
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