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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

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MAUDE LookupStructural HeartPASCAL PRECISION

PASCAL PRECISION Adverse Events: FDA MAUDE Data

Edwards Lifesciences LLC · Transcatheter Mitral Valve Repair (TEER) · First cleared Sep 2022

Total Reports

243

Reports (30d)

228

Active Signals

1

Open Recalls

1

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Unplanned Cardiac Intervention Late Post-ImplantEmerging

surgery intervention, position cardiac, intervention unplanned, unplanned pod, pod edwards

35

reports

2

Unplanned Mitral Valve Intervention Same DayEmerging

surgery intervention, mitral valve, tricuspid, unplanned, pod edwards

31

reports

3

Unplanned Mitral Valve Reintervention Late Post-ImplantEmerging

mitral valve, position cardiac, unplanned, reintervention, pod edwards

29

reports

4

Permanent Pacemaker Implant Same DayEmerging

position permanent, pacemaker implanted, implanted pod, permanent, permanent pacemaker

22

reports

5

Readmission Late Post-ImplantEmerging

pod edwards

12

reports

6

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

Active safety signals

Volume spikecritical

Regulatory

FDA recalls for this device

Class II

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

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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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.