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TRV-2026-0047Version 1 · Certified

Written 2026-07-12 20:50:18 UTC · current record

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TRUVACE RECORD VERSION
record: TRV-2026-0047
version: 1
kind: certified
reason: Certified into the record
timestamp: 2026-07-12T20:50:18.089538Z
status: published
lens: p_space
sector: health
headline: Evolut r transcatheter aortic valve: FDA injury report involving AI
dek: 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.
gain_reading: (none)
problem_reading: 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.
limitation: FDA adverse-event reports can be incomplete, duplicated, or unverified and do not establish that a device caused the reported outcome.
tag: Evidence-backed problem
key_points: Device: Evolut r transcatheter aortic valve; manufacturer: Medtronic mexico s. de r.l. de cv. | FDA report type: Injury. | An adverse-event report is a safety signal, not proof that the device caused the event.
rundown: 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.

The report is part of FDA’s MAUDE surveillance data. It should be read as a signal for follow-up, not a clinical conclusion or a verified incidence rate.
sources:
- government | FDA MAUDE report 24706346 | https://api.fda.gov/device/event.json?search=mdr_report_key%3A%2224706346%22&sort=date_received%3Adesc&limit=1 | 2026-03-26
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