Edwards Lifesciences LLC · Transcatheter Mitral Valve Repair (TEER) · First cleared Sep 2022
Total Reports
243
Reports (30d)
228
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Unplanned Cardiac Intervention Late Post-ImplantEmerging
surgery intervention, position cardiac, intervention unplanned, unplanned pod, pod edwards
35
reports
Unplanned Mitral Valve Intervention Same DayEmerging
surgery intervention, mitral valve, tricuspid, unplanned, pod edwards
31
reports
Unplanned Mitral Valve Reintervention Late Post-ImplantEmerging
mitral valve, position cardiac, unplanned, reintervention, pod edwards
29
reports
Permanent Pacemaker Implant Same DayEmerging
position permanent, pacemaker implanted, implanted pod, permanent, permanent pacemaker
22
reports
Readmission Late Post-ImplantEmerging
pod edwards
12
reports
Ischemic Stroke Same Day Post-ImplantEmerging
stroke, ischemic, pod edwards
12
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Jul 27, 2023 · Open, Classified
Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation.
Evidence
Mitral Transcatheter Edge-to-Edge Repair With the PASCAL Precision System: Device Knobology and Review of Advanced Steering Maneuvers
Santiago García, et al. · Structural Heart · 2023
Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System
Thomas Waggoner, et al. · JACC: Cardiovascular Interventions · 2025
Mission M-Possible: Mitral Transcatheter Edge-to-Edge Repair in Mitral Annular Calcification Using the Crab-Walk Technique.
Abdelmalek J, et al. · 2025
Transcatheter Valve Repair for Tricuspid Regurgitation
Mirjam G. Wild, et al. · Journal of the American College of Cardiology · 2024
Citations indexed from PubMed.
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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.
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