MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number COREVALVE EVOLUT PRO & ENVEO SYSTEM (23MM, 26MM, 29MM, & 34MM) |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Tvt registry exemption number: e2014038 quarterly reporting period: q1 2022 total number of events being summarized: 1 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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Event Description
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The type of malfunction reported was a device fracture.The time to event was not reported.The patient¿s age in this report was (b)(6).The patient was female.The type of malfunction 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 (b)(6).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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Search Alerts/Recalls
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