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TruaceTracing the truth around AISunday, July 12, 2026
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TRV-2026-0047Certified recordOfficial statistics

Evolut r transcatheter aortic valve: FDA injury report involving AI

The FDA received a injury report involving Evolut r transcatheter aortic valve, made by Medtronic mexico s. de r.l. de cv. It was reported that 7 months following the implant of a transcatheter aortic valve, leaflet thickening was identified via computed tomography angiogram (cta) that was further analyzed via a non-medtronic artificial intelligence (ai)-powered simulation. the patient is being evaluated for a transcatheter valve-in-valve procedure.

Health · P Space — documented harm · certified 2026-07-12 · v1 · article view · machine-readable

Current reading — problem

An FDA adverse-event report linked Evolut r transcatheter aortic valve to an AI-related injury; the report requires investigation and does not by itself establish causality.

What this doesn’t fix

FDA adverse-event reports can be incomplete, duplicated, or unverified and do not establish that a device caused the reported outcome.

Evidence

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Truvace Impact Record TRV-2026-0047, v1: “Evolut r transcatheter aortic valve: FDA injury report involving AI.” Truvace, 2026-07-12. /record/TRV-2026-0047 (accessed at citation time). sha256 85ef2873895dc0fd…

Calibration history

Every change to this record since certification, in the open. None yet — the reading has held since it entered the record.

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