EVOLUT PRO TRANSCATHETER AORTIC VALVE

Description of Event or Problem

The type of serious injuries being reported are unplanned unspecified vascular surgery or interventions and unspecified minor vascular complications. The average time to event was zero days following the implant procedure. The patients' ages were 86. There were 2 males. 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.

Additional Manufacturer Narrative

TVT Registry Exemption Number: E2014038 Quarterly Reporting Period: Q2 2026 Total number of events being summarized: 2 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. 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.