Edwards Lifesciences LLC · Transcatheter Mitral Valve Repair (TEER) · First cleared Sep 2022
Total Reports
1,559
Reports (30d)
955
Active Signals
3
Open Recalls
1
What the reports describe · Claripulse analysis
Unplanned Cardiac Surgery 48 Days Post-ProcedureEmerging
surgery intervention, cardiac surgery, position cardiac, intervention unplanned, unplanned days
109
reports
Cardiac Readmission 267 Days Post-ProcedureEmerging
cardiac heart, failure pod, readmission cardiac, expired pod, expired
91
reports
Cardiac Readmission 327 Days Post-ProcedureEmerging
cardiac heart, heart failure, readmission cardiac, failure days, position readmission
84
reports
Mitral Valve Reintervention 35 Days Post-ProcedureEmerging
reintervention mitral, position reintervention, mitral valve, alive, days procedure
72
reports
Permanent Pacemaker Implant on POD 0Emerging
status alive, pod patient, pacemaker implanted, permanent, permanent pacemaker
69
reports
Cardiac Readmission 18 Days Post-ProcedureEmerging
cardiac heart, heart failure, readmission cardiac, failure days, position readmission
58
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
PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies in complex primary mitral regurgitation
Muhammed Gerçek, et al. · Clinical Research in Cardiology · 2021
Initial Experience With the PASCAL Ace Implant System for Treatment of Severe Tricuspid Regurgitation
Matthias Aurich, et al. · Circulation Cardiovascular Interventions · 2021
Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30‐day results
Stephan Baldus, et al. · Catheterization and Cardiovascular Interventions · 2022
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. 3 active signals detected right now.
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