ClaripulseClaripulse™
Get Early Access
Back to Structural Heart

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve Adverse Events: FDA MAUDE Data

Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015

Total Reports

13,485

Reports (30d)

183

Active Signals

1

Open Recalls

0

Monthly Report Volume
No timeline data available.
Event Type Breakdown
No event type data available.

Detection

Active safety signals

Disproportionate reportinghigh

Keep exploring

Related devices in Structural

MitraClip

ABBOTT VASCULAR INC. · 18,209 reports

→

Evolut FX

MEDTRONIC, INC. · 12,636 reports

→

Evolut PRO

MEDTRONIC, INC. · 7,566 reports

→

CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC

Edwards Lifesciences LLC · 6,121 reports

→

CoreValve Evolut

MEDTRONIC, INC. · 4,371 reports

→

WATCHMAN

BOSTON SCIENTIFIC CORPORATION · 3,826 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. 1 active signal detected right now.

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.