Adverse events after transcatheter edge-to-edge repair: descriptive post-marketing surveillance analysis of MitraClip and PASCALTM from the Manufacturer and User Facility Device Experience (MAUDE) registry.

BACKGROUND

Transcatheter edge-to-edge repair (TEER) has emerged as a pivotal intervention for patients with severe mitral regurgitation (MR). The MitraClip and PASCALTM devices are two leading percutaneous devices developed for TEER. While both devices are effective, comparative real-world adverse event data between the two remain limited. This study aims to analyze the post-marketing device-related adverse event profiles associated with the MitraClip and PASCAL device using the Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database.

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% vs. 20.83%, 95% confidence interval (CI): 1.408-13.855; P=0.005]. Valve apparatus tear reports between the two devices were similar (24.49% vs. 16.66%, 95% CI: 0.529-6.648; P=0.47). Device embolization was also similar when the MitraClip group was compared to those who received the PASCALTM device (7.90% vs. 4.17%, 95% CI: 0.303-83.250; P>0.99). Mortality and other major complications, such as cardiogenic shock and pericardial effusion, were rare and statistically similar between both groups.

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.