Adverse events after transcatheter edge-to-edge repair: descriptive post-marketing surveillance analysis of MitraClip and PASCAL

Background: Transcatheter edge-to-edge repair (TEER) has emerged as a pivotal intervention for patients with severe mitral regurgitation (MR). The MitraClip and PASCAL Methods: We queried the MAUDE database from September 2022 to August 2025 for device-related adverse events reported for the MitraClip and PASCAL systems in the United States. After excluding duplicate reports, 518 reports were included in this study. Adverse events were categorized into 13 clinical outcomes, with comparative analyses being performed for each category. Results: Of the adverse events reported, device detachment or malfunction was the most frequently reported device-related event and was more common with the MitraClip than the PASCAL system [47.98% Conclusions: This MAUDE-based post-marketing analysis identifies device detachment/malfunction during device deployment as the most frequently reported event category among submitted reports, particularly in the MitraClip cohorts and among patients receiving the PASCALTM for severe MR. However, due to passive reporting, lack of denominator data, and marked cohort imbalance, these findings are descriptive and hypothesis-degenerating rather than definitive comparative safety outcomes.