EnVeo PRO Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Jan 2018 · 5 device variants grouped
Total Reports
902
Reports (30d)
4
Active Signals
2
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Deployment Issues with Delivery Catheter
deployment, dcs, catheter dcs, balloon, delivery catheter
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Jun 11, 2021 · Open, Classified
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Jun 11, 2021 · Open, Classified
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
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
Propensity matched analysis of vascular complications using integrated or expandable sheaths for TAVR.
Ruge H, et al. · Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2022
Propensity Matched Analysis of 14 French Suture- Versus Plug-Based Vascular Closure During Transfemoral Transcatheter Aortic Valve Replacement (TAVR).
Lerchner T, et al. · Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025
Predicting the risk of iliofemoral vascular complication in complex transfemoral-TAVR using new generation transcatheter devices
Ofir Koren, et al. · Frontiers in Cardiovascular Medicine · 2023
Comparison of Evolut-R 34 mm Valve and Smaller Evolut-R Valves in Patients Undergoing Transcatheter Aortic Valve Implantation and Determination of Mild Paravalvular Leak Predictors
Raif Kılıç · The Anatolian Journal of Cardiology · 2024
Emergency bailout surgery saves lives in high‐risk patients with complications after TAVR
Nicolas Combaret, et al. · Journal of Cardiac Surgery · 2022
Citations indexed from PubMed.
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