MEDTRONIC HEART VALVES DIVISION MEDTRONIC TRANSCATHETER VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number MDT-TRANS VALVE |
Device Problems
Gradient Increase (1270); Patient Device Interaction Problem (4001); Central Regurgitation (4068)
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Patient Problems
Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 03/13/2024 |
Event Type
Injury
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Manufacturer Narrative
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Citation: alperi et al. hemodynamic performance of self-expandable transcatheter aortic valve replacement systems during valve deployment. j invasive cardiol 2024.Doi:10.25270/jic/23.00286.Epub march 13, 2024.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 hemodynamic performance of self-expandable transcatheter aortic valves during deployment.The study population included 19 patients with a median age of 83.8 years who were predominantly male. multiple manufacturer¿s devices were implanted in the study population; 15 patients were implanted with a medtronic evolut r, evolut pro or evolut pro+ bioprosthetic valve. among all patients adverse events included: high mean and peak gradients, stroke, arrhythmia requiring permanent pacemaker implant, major vascular complication, and moderate to severe aortic regurgitation. no further information was provided pertaining to medtronic products.
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