MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number COREVALVE EVOLUT R & ENVEO SYSTEM (23MM, 26MM, 29MM, & 34MM) |
Device Problem
Insufficient Information (3190)
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Patient Problem
Endocarditis (1834)
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Event Date 11/06/2022 |
Event Type
Injury
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Event Description
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The type of serious injuries being reported are endocarditis.The average time to event was two hundred fifty-four days following the implant procedure.The patient ages in this report range from 67 to 83.There were 3 males and 1 female.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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Manufacturer Narrative
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Tvt registry exemption number: e2014038 quarterly reporting period: q4 2022 total number of events being summarized: 4 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 in section a.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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Search Alerts/Recalls
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