TriClip Adverse Events: FDA MAUDE Data

ABBOTT (ST. JUDE MEDICAL) · Transcatheter Tricuspid Valve Repair · First cleared Aug 2025 · 8 device variants grouped

Total Reports

2,022

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Suboptimal Clip Attachment with Secondary Intervention

sub, regurgitation triclip, delay reported, sub optimal, procedure clinically

117

reports

Single Leaflet Device Attachment During Deployment

deployed tricuspid, regurgitation grade, performed treat, reducing, reducing grade

reports

Long-Term Mortality Post-Repair with PCS

years

reports

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

Evidence

Related research

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

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

Georgios E Papadopoulos, et al. · Reviews in Cardiovascular Medicine · 2025

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

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

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

Georgios E 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.