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TRV-2026-0038Version 2 · Revised

Written 2026-07-12 20:58:06 UTC · current record

Reason for this version

Reading revised

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TRUVACE RECORD VERSION
record: TRV-2026-0038
version: 2
kind: revised
reason: Reading revised
timestamp: 2026-07-12T20:58:06.530956Z
status: published
lens: p_space
sector: health
headline: Mitraclip® system clip delivery system: FDA death report involving AI
dek: The FDA received a death report involving Mitraclip® system clip delivery system, made by Abbott medical. The article, "predicting outcomes in patients with tricuspid regurgitation undergoing transcatheter edge-to-edge repair using an artificial intelligence¿derived risk score", was reviewed. this research article is a retrospective multicenter experience to evaluate and validate a robust, reliable risk score for predicting mortality and clinical outcomes in patients undergoing tricuspid- transcatheter edge-to-e…
gain_reading: (none)
problem_reading: An FDA adverse-event report linked Mitraclip® system clip delivery system to an AI-related death; 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: Mitraclip® system clip delivery system; manufacturer: Abbott medical. | FDA report type: Death. | An adverse-event report is a safety signal, not proof that the device caused the event.
rundown: The article, "predicting outcomes in patients with tricuspid regurgitation undergoing transcatheter edge-to-edge repair using an artificial intelligence¿derived risk score", was reviewed. this research article is a retrospective multicenter experience to evaluate and validate a robust, reliable risk score for predicting mortality and clinical outcomes in patients undergoing tricuspid- transcatheter edge-to-edge repa…

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 24887354 | https://api.fda.gov/device/event.json?search=mdr_report_key%3A%2224887354%22&sort=date_received%3Adesc&limit=1 | 2026-04-15
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