PASCAL Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Mitral Valve Repair (TEER) · First cleared Sep 2022 · 4 device variants grouped
Total Reports
1,950
Reports (30d)
29
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Single Leaflet Device Attachment Post-Implant
received notification, ace, notification pascal, edwards received, pascal
67
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.
Evidence
Related research
Adverse events after transcatheter edge-to-edge repair: descriptive post-marketing surveillance analysis of MitraClip and PASCAL<sup>TM</sup> from the Manufacturer and User Facility Device Experience (MAUDE) registry.
Kommuri A, et al. · Journal of thoracic disease · 2026
A Pascal in ring: Transcatheter edge-to-edge tricuspid repair for severe regurgitation within a surgical annuloplasty ring.
Chahid S, et al. · Annales de cardiologie et d'angeiologie · 2026
One-Year Outcomes of M-TEER With the PASCAL System in Atrial and Ventricular FMR: Insights From the MiCLASP Postmarket Clinical Follow-Up Study.
Mahabadi AA, et al. · Circulation. Cardiovascular interventions · 2026
Transcatheter Edge-to-Edge Repair With MitraClip G4 System Compared With PASCAL System in Patients With Functional Mitral Regurgitation: A Propensity Score-Matched Analysis.
Ackermann P, et al. · Journal of the American Heart Association · 2026
Challenging the limits of mitral-TEER: a PASCAL case in the anatomical 'red zone': a case report.
Papadopoulos K, et al. · European heart journal. Case reports · 2026
Citations indexed from PubMed.
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