TriClip Adverse Events: FDA MAUDE Data

ABBOTT (ST. JUDE MEDICAL) · Transcatheter Tricuspid Valve Repair · First cleared Aug 2025

Total Reports

1,322

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Single Leaflet Device Attachment During Implant

reported incident, limited, registry, rates, based

reports

Literature Batch: Residual Tricuspid Regurgitation Outcomes

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Early signalcritical

Evidence

Related research

Transcatheter Edge-to-Edge Repair of Tricuspid Regurgitation With TriClip: A Step-by-Step Guide

G. Papadopoulos, et al. · Reviews in Cardiovascular Medicine · 2025

Tricuspid Valve Transcatheter Edge-to-Edge Repair (TriClip): Initial Outcomes and Experience in Türkiye

Fuat Polat · Turk Kardiyoloji Dernegi Arsivi-Archives of the Turkish Society of Cardiology · 2024

Combined MitraClip and TriClip therapy in patients with severe mitral and tricuspid regurgitation: determinants and prediction of mid-term outcomes

Giuseppe Ancona, et al. · Frontiers in Cardiovascular Medicine · 2026

Efficacy and Safety of TriClip Procedure in Patients with Severe Tricuspid Regurgitation and Large Coaptation Gap

Zeynettin Kaya, et al. · Cardiovascular Drugs and Therapy · 2025

Combined mitral and tricuspid TEER with a single TriClip steerable guide catheter: A single-center study

G. Papadopoulos, et al. · Cardiovascular revascularization medicine · 2025

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.