Evolut PRO Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Jan 2014 · 13 device variants grouped

Total Reports

7,401

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Detection

Active safety signals

Disproportionate reportinghighDisproportionate reportinghighIncreasing trendmediumDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghigh

Regulatory

FDA recalls for this device

Class II

Jun 11, 2021 · Open, Classified

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

Class II

Jun 11, 2021 · Open, Classified

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

Class II

Jun 11, 2021 · Open, Classified

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

Evidence

Related research

Analysis of aortic valve prostheses using advanced cardiovascular imaging-a patient-specific reversed translational approach.

Grefen L, et al. · 2026

Self-Expandable Transcatheter Aortic Valve Frame Infolding: An Increasingly Recognized Complication

Gurpreet Singh, et al. · European Journal of Case Reports in Internal Medicine · 2020

Thirty-day clinical outcomes of the Evolut PRO self-expanding transcatheter aortic valve: the international FORWARD PRO study

Ganesh Manoharan, et al. · EuroIntervention · 2020

Early Real-World Experience with CoreValve Evolut PRO and R Systems for Transcatheter Aortic Valve Replacement.

Rao G, et al. · 2019

Successful Treatment of Severe Paravalvular Leak by Repositioning a Self-Expandable Percutaneous Aortic Valve Bioprosthesis (Evolut PRO+) Using the “Double Snare” Technique

Diego H. González-Bravo, et al. · Case Reports in Cardiology · 2022

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

→

CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC

Edwards Lifesciences LLC · 6,040 reports

→

CoreValve Evolut

MEDTRONIC, INC. · 4,236 reports

→

WATCHMAN

BOSTON SCIENTIFIC CORPORATION · 3,797 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. 10 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.