Tvt registry exemption number: e2014038 quarterly reporting period: q1 2024 total number of events being summarized: 6 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.The views or opinions presented here do not represent those of the american college of cardiology foundation, the society of thoracic surgeons, or the sts/acc tvt registry.The industry data file upon which the analysis was performed is a subset of the full sts/acc tvt registry data submissions.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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