Abstract 4370319: Early Safety Signals and Common Pitfalls of the TriClip™ System for Transcatheter Tricuspid Valve Repair: Analysis of FDA's MAUDE Database

Abstract

Background: Tricuspid regurgitation (TR) can lead to right ventricular failure (RVF) and poor clinical outcomes. The TriClip™ G4 transcatheter edge-to-edge repair (TEER) system has shown improved outcomes in TR patients and received FDA approval on April 2, 2024. The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database collects mandatory manufacturer reports and voluntary provider reports on device-related complications. Methods: We retrieved all TriClip™-related adverse events from the MAUDE database post-FDA approval, excluding duplicate entries and literature reviews. After removing 47 literature reviews and 36 duplicate reports, 443 unique adverse event reports from 407 procedures (some with multiple events) were analyzed between April 2, 2024, and January 31, 2025. Results: SLDA (Single Leaflet Device Attachment) was the most frequent complication, occurring in 204 cases (Figure 1). Detached leaflets included septal (105 cases), anterior (46), posterior (27), lateral (3), multiple (2), and unreported. Contributing factors included poor imaging, tethered leaflet, clip-clip interaction, dense chordae, large right atrium (RA) or gap size, pacer lead, or prior valve intervention. Persistent TR was a common consequence. SLDA was addressed with additional clips in 77 cases (18 requiring multiple clips), no intervention in 55 cases (13 with significant residual TR), repeat TriClip procedures in 16 cases, and surgical repair in 4 cases. Other complications included partial SLDA (23 cases), clip deployment or gripper malfunctions (68), chordal entanglement (41), leaflet entanglement (3), and clip migration/embolization (6). Migrated clips were found in the RA, right atrial appendage, cardiac vein, or pulmonary artery; three required snare retrieval, and three were left in place. Triclip Steerable Guide Catheter (TSGC) malfunctions, such as leaks, loss of column support, and blockages, were reported in 29 cases, with 27 requiring replacement. Miscellaneous events included residual TR, leaflet grasping issues, F-knob malfunction, lock line jams, and TSGC entanglement. Clip opening during Establishing Final Arm Angle (EFAA) occurred in 25 cases, and leaflet puncture in 15 cases, with one requiring surgical intervention. Conclusion: SLDA was the most frequently reported complication following TriClip™ approval, with some cases leading to severe outcomes. Continued surveillance is crucial to assess long-term safety and optimize procedural strategies.