PASCAL Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Mitral Valve Repair (TEER) · First cleared Sep 2022
Total Reports
1,802
Reports (30d)
19
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Cardiac Readmission on Post-Operative Day 273
failure pod, readmission cardiac, expired pod, position readmission, pod
122
reports
Unplanned Cardiac Intervention 48 Days Post-Procedure
surgery intervention, cardiac surgery, position cardiac, intervention unplanned, unplanned days
100
reports
Cardiac Readmission Eighty-Five Days Post-Procedure
cardiac heart, days procedure, readmission cardiac, failure days, position readmission
98
reports
Permanent Pacemaker Implant on Post-Operative Day 0
pod patient, position permanent, pacemaker implanted, implanted pod, permanent pacemaker
91
reports
Cardiac Readmission Three Hundred Twenty-Seven Days Post-Procedure
cardiac heart, days procedure, readmission cardiac, failure days, position readmission
83
reports
Single Leaflet Device Attachment Day After Procedure
leaflet, slda, severe, regurgitation, ace
79
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
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.
Keep exploring
Related devices in Structural
MitraClip
ABBOTT VASCULAR INC. · 18,209 reports
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC · 13,485 reports
Evolut FX
MEDTRONIC, INC. · 12,636 reports
Evolut PRO
MEDTRONIC, INC. · 7,566 reports
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC
Edwards Lifesciences LLC · 6,121 reports
CoreValve Evolut
MEDTRONIC, INC. · 4,371 reports
Want automated safety signal detection?
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.
Get Early AccessUnderstanding this data