+ HEALTH Aims Intramuscular fat (IMF) is increasingly recognized as a marker of ectopic adiposity and adverse cardiome…+ HEALTH Periapical lesions are challenging to detect on intraoral radiographs because of anatomical superimposition a…± HEALTH Ultrasound imaging is an indispensable diagnostic tool, yet its profound reliance on operator expertise inher…+ HEALTH Objectives We adapted the individualized polysocial risk score (iPsRS), a machine learning model originally d…± HEALTH Melioidosis is a life-threatening infectious disease caused by Burkholderia pseudomallei ( Bp ). Rapid diagno…+ HEALTH Classification is a core machine learning task, and ensemble voting methods are widely used to improve predic…+ CLIMATE Microplastic (MP) pollution poses escalating environmental risks, demanding efficient and reproducible tools…± HEALTH Medicinal chemistry sits at the center of modern drug discovery, yet translating molecular designs into appro…
TruaceTracing the truth around AIWednesday, August 26, 2026
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TRV-2026-0047Retracted — remains on the 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 · v2 · article view · machine-readable

This record was retracted on 2026-07-13 — Model backfill: source did not support a publishable AI-impact claim. It remains permanently retrievable here, as does every prior version below.
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

Cite this record

Truvace Impact Record TRV-2026-0047, v2: “Evolut r transcatheter aortic valve: FDA injury report involving AI.” Truvace, 2026-07-13. /record/TRV-2026-0047 (accessed at citation time). sha256 57677deb2aecc26d…

Calibration history

Every change to this record since certification, in the open.

  1. Retractedv257677deb2aec…

    Model backfill: source did not support a publishable AI-impact claim

  2. Certifiedv185ef2873895d…

    Certified into the record

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