EnVeo R Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015 · 7 device variants grouped
Total Reports
544
Reports (30d)
2
Active Signals
3
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Literature Batch: Self-Expanding Valve Outcomes
devices, evolut, patients, study, included
3
reports
Deployment Issues with Delivery Catheter
deployment, dcs, catheter dcs, balloon, delivery catheter
1
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
First-in-human experience with the Medtronic CoreValve Evolut R.
Piazza N, et al. · EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2014
From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves.
Mahtta D, et al. · Cardiology and therapy · 2017
Final 3‐year clinical outcomes following transcatheter aortic valve implantation with a supra‐annular self‐expanding repositionable valve in a real‐world setting: Results from the multicenter FORWARD study
Nicolas M. Van Mieghem, et al. · Catheterization and Cardiovascular Interventions · 2021
Mid-term outcomes of patients with Lotus and Evolut transcatheter valves
Petr Hájek, et al. · Advances in Interventional Cardiology · 2022
Vascular Complications in TAVR: Incidence, Clinical Impact, and Management.
Mach M, et al. · Journal of clinical medicine · 2021
Citations indexed from PubMed.
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