EVOLUT FX PLUS VALVE
Received Jul 31, 2026 · Event occurred Jun 19, 2026
Report 9617601-2026-04842 · MDR key 50094275
Device
Generic name
Aortic Valve, Prosthesis, Percutaneously Deliv
Manufacturer
Medtronic Mexico S. De R.l. De CvModel number
EVFXPLUS-29Catalog number
EVFXPLUS-29
Product problems
- Patient Device Interaction Problem
Patient
Not reported
- Stroke/CVA
Narrative
Description of Event or Problem
It was reported that one day following the implant of a transcatheter aortic bioprosthetic valve, the patient experienced a stroke.
Additional Manufacturer Narrative
A. Select Patient Information cannot be included in the Regulatory Report due to regional privacy regulations. 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.