COMMANDER Adverse Events: FDA MAUDE Data

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

Total Reports

249

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Delivery System Failure During Procedure

ultra, sheath, delivery, esheath, balloon

reports

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

Detection

Active safety signals

Disproportionate reportinghigh

Evidence

Related research

Machine learning approach to identify phenotypes in patients with ischaemic heart failure with reduced ejection fraction.

Monzo L, et al. · 2024

A Systematic Review and Meta-Analysis of Preoperative Biliary Drainage Methods in Periampullary Tumors.

Moldovan SA, et al. · 2025

Emergency Medical Commander: a multimethod case study applying the lens of Path-Goal leadership theory.

Michael AJF, et al. · 2026

Rivaroxaban to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease: a narrative review.

Abdul-Rahman T, et al. · 2025

The Role of GDF-15 in Heart Failure and Biomarker Potential-From Basic Science to Clinical Praxis.

Barbosa M, et al. · 2026

Citations indexed from PubMed.

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. 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.