ClaripulseClaripulse
MAUDE LookupResourcesBlog
LoginGet Early Access
ClaripulseClaripulse

Product

MAUDE LookupDashboard

Guides

FDA MAUDE DatabasePost-Market SurveillanceSignal Detection

Learn

BlogResourcesWhy Claripulse?

Legal

Privacy PolicyTerms of Service

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.

Back to Structural Heart
MAUDE LookupStructural HeartLOTUS Edge Valve System

LOTUS Edge Valve System Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Transcatheter Aortic Valve (TAVR) · First cleared Mar 2020

Total Reports

949

Reports (30d)

0

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Literature Batch: TAVR Clinical Outcomes

devices, evolut, patients, study, included

1

reports

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

Keep exploring

Related devices in Structural

MitraClip

ABBOTT VASCULAR INC. · 17,746 reports

→

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

Edwards Lifesciences LLC · 13,096 reports

→

Evolut FX

MEDTRONIC, INC. · 11,918 reports

→

Evolut PRO

MEDTRONIC, INC. · 7,401 reports

→

CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC

Edwards Lifesciences LLC · 6,040 reports

→

CoreValve Evolut

MEDTRONIC, INC. · 4,236 reports

→

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.

Get Early Access

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.

→

How a safety signal is detected

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

→
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.