TRV-2026-0043Version 3 · Retracted
Reason for this version
Model backfill: source did not support a publishable AI-impact claim
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TRUVACE RECORD VERSION record: TRV-2026-0043 version: 3 kind: retracted reason: Model backfill: source did not support a publishable AI-impact claim timestamp: 2026-07-13T00:40:23.501906Z status: archived lens: p_space sector: health headline: Mitraclip® system clip delivery system: FDA injury report involving AI dek: The FDA received a injury 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-… gain_title: (none) problem_title: An FDA adverse-event report linked Mitraclip® system clip delivery system to an AI-related injury; the report requires investigation and does not by itself establish causality. trace_subject: (none) gain_reading: (none) problem_reading: An FDA adverse-event report linked Mitraclip® system clip delivery system to an AI-related injury; the report requires investigation and does not by itself establish causality. quick_read: The FDA received a injury 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… 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: Injury. | 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 24887023 | https://api.fda.gov/device/event.json?search=mdr_report_key%3A%2224887023%22&sort=date_received%3Adesc&limit=1 | 2026-04-15 prev: 41c08d992863940c1f51e6fe8f23d50a5a4634649b1bd1d73148011f30494dfc
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- 41c08d992863940c1f51e6fe8f23d50a5a4634649b1bd1d73148011f30494dfc
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