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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

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MAUDE LookupStructural HeartTriClip

TriClip Adverse Events: FDA MAUDE Data

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

Total Reports

1,097

Reports (30d)

48

Active Signals

2

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Single Leaflet Detachment During Procedure

clip, septal, triclip procedure, grade, clinically

100

reports

2

Literature Batch: Edge-to-Edge Repair Outcomes

stroke, edge repair, years, university, cologne

19

reports

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

Detection

Active safety signals

Increasing trendcriticalDisproportionate reportinghigh

Evidence

Related research

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

Papadopoulos GE, et al. · 2025

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

Kaya Z, et al. · 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

Tricuspid Transcatheter Edge-to-Edge Repair in Patients With Transvalvular CIED Leads

Hursh Naik, et al. · JACC. Clinical electrophysiology · 2025

Tricuspid Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation

Gilbert H.L. Tang, et al. · Journal of the American College of Cardiology · 2024

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.