Mitraclip® system clip delivery system: FDA death report involving AI
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…
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.
FDA adverse-event reports can be incomplete, duplicated, or unverified and do not establish that a device caused the reported outcome.
Evidence
- GovernmentFDA MAUDE report 248873542026-04-15
Truvace Impact Record TRV-2026-0038, v2: “Mitraclip® system clip delivery system: FDA death report involving AI.” Truvace, 2026-07-12. /record/TRV-2026-0038 (accessed at citation time). sha256 896d13e72c210beb…
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