PASCAL Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Mitral Valve Repair (TEER) · First cleared Sep 2022
Total Reports
1,836
Reports (30d)
0
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Detached Leaflet Device Attachment Post-Procedure
received notification, ace, notification pascal, notification, pascal
48
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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.
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