EVOLUT PRO PLUS VALVE

Description of Event or Problem

It was reported that approximately 6 years and 5 months following the implant of a transcatheter aortic valve, the valve failed due to severe central aortic regurgitation. The patient suffered congestive heart failure (CHF) and was re-hospitalized as a result.

Additional Manufacturer Narrative

This report was impacted by eMDR scheduled maintenance occurring (b)(6) 2026. 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.