MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number COREVALVE EVOLUT R & ENVEO SYSTEM (23MM, 26MM, 29MM, & 34MM) |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Information (3190)
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Event Date 08/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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Tvt registry exemption number: e2014038 quarterly reporting period: q3 2020 total number of events being summarized: 5 under the terms and conditions of the registry, anonymized patient demographics details and limited details were provided regarding the adverse events and outcomes.The listed event date is the date the information was received by medtronic.The patient information included.Is an average of the data provided for the events.A product analysis was not able to be performed as no product was returned.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
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Event Description
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This report summarizes <(><<)>noe> 5 <(><<)>/noe> serious injury events.The type of serious injuries reported were events resulting in cardiopulmonary bypass.The average time to event was zero days following the implant procedure.The patient ages in this report range from 57 to 87 there were 5 males and 0 females.The type of serious injury information provided is limited in nature as it is provided via a third-party database.Medtronic received information regarding patient/device events via a third-party post-implant device registry (the society of thoracic surgeons/american college of cardiology transcatheter valve therapy registry).The information in this report was provided to medtronic in a de-identified format and has been organized into summaries of observations related to patient serious injuries.
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