LOTUS Edge Valve System Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Transcatheter Aortic Valve (TAVR) · First cleared Mar 2020 · 3 device variants grouped
Total Reports
1,235
Reports (30d)
2
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Death Two Months Post-Implant
artery, following implant, bioprosthetic, implant transcatheter, months
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Optimal Oversizing Index Depending on Valve Type and Leakage-Proof Function for Preventing Paravalvular Leakage after Transcatheter Aortic Valve Implantation
You‐Jeong Ki, et al. · Journal of Clinical Medicine · 2020
Prosthesis Tailoring for Patients Undergoing Transcatheter Aortic Valve Implantation
Pier Pasquale Leone, et al. · Journal of Clinical Medicine · 2023
Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis: A Practical Operative Overview
Giuseppe Tarantini, et al. · Circulation Cardiovascular Interventions · 2021
The incidence and impact of cardiac conduction disturbances after transcatheter aortic valve replacement
Shmuel Chen, et al. · Annals of Cardiothoracic Surgery · 2020
Over 15 years: the advancement of transcatheter aortic valve replacement
Thomas J. Cahill, et al. · Annals of Cardiothoracic Surgery · 2020
Citations indexed from PubMed.
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