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Health·P Space·Evidence-backed problem·Published 2026-07-12

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…

TRV-2026-0038Official statisticsPermanent record — cite & verify
Mitraclip® system clip delivery system: FDA death report involving AI

"Medical laboratories and clinics in Kinwat" by Mouryan, CC BY-SA 4.0.

The quick read

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-edge repa…

Main 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.
Problem

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.

The 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

The debate