ClaripulseClaripulse™
Get Early Access
Back to Coronary Intervention

Resolute Onyx Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Coronary Drug-Eluting Stent · First cleared Apr 2017 · 139 device variants grouped

Total Reports

4,478

Reports (30d)

4

Active Signals

2

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Detection

Active safety signals

Disproportionate reportinghighDisproportionate reportinghigh

Keep exploring

Related devices in Coronary

Perclose ProGlide

ABBOTT VASCULAR INC. · 24,591 reports

→

Perclose ProStyle

ABBOTT VASCULAR INC. · 19,487 reports

→

PERCLOSE

ABBOTT VASCULAR INC. · 10,006 reports

→

Angio-Seal

TERUMO MEDICAL CORPORATION · 6,574 reports

→

SYNERGY

BOSTON SCIENTIFIC CORPORATION · 6,056 reports

→

Promus PREMIER

BOSTON SCIENTIFIC CORPORATION · 2,735 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. 2 active signals 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.