Key result
The proportion of fatal events among reported MitraClip casualties declined ~78% over the study period.
Why the study?
To evaluate trends in safety outcomes by analyzing death events associated with MitraClip implantation over a 10-year period using the FDA MAUDE database.
What are the trends and characteristics of fatal events associated with MitraClip implantation reported in the FDA MAUDE database over a 10-year period?
Observational (n=8,941)
What are the trends and characteristics of fatal events associated with MitraClip implantation reported in the FDA MAUDE database over a 10-year period?
Absolute Event Rate: 3.5% vs 15.9%
p-value: p=<0.0001
Analysis of the FDA MAUDE database over a 10-year period reveals a significant decline in the proportion of fatal events associated with MitraClip implantation, likely reflecting improved operator experience and device design.
Declining MAUDE fatality proportions suggest possible safety gains with experience; observational data leave causal confirmation and practice change open.
BACKGROUND: The transcatheter edge-to-edge repair (TEER) technique, facilitated by the MitraClip device, is a minimally invasive intervention designed for high-risk patients with mitral regurgitation (MR). This study conducts a retrospective analysis of death events associated with MitraClip implantation over a ten-year decade, utilizing data from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database to evaluate trends in safety outcomes. METHODS: A comprehensive search of the publicly accessible MAUDE database was conducted to retrieve reports of deaths and injuries related to MitraClip implantation from October 2013 to September 2023. Duplicate reports and records from unrelated sources were excluded. The Cochran-Armitage test was performed to evaluate trends in the proportion of fatal events over time. RESULTS: During the 10-year period following FDA approval, the MAUDE database recorded a total of 927 death reports and 9,211 injury reports associated with MitraClip. After excluding duplicates and irrelevant reports, 592 death cases were analyzed. The most commonly reported complications were MR (26.69%), tissue damage (24.16%), and hypotension (22.13%). The most frequent device-related issues were incomplete coaptation (14.70%), difficulty removing the divice (6.42%), and failure to adhere or bond/positioning failure(4.90%). Notably, 76.94% of deaths occurred within one year of implantation. The proportion of fatal events demonstrated a gradual decline, from 15.9% in 2014-2015 to 3.5% in 2020-2021 (p < 0.0001). CONCLUSIONS: This analysis of the MAUDE database indicates a gradual decline in the proportion of fatal events associated with MitraClip implantation, which may be attributed to growing operator experience and advancements in device design. Nonetheless, persistent focus is required on managing complications and addressing potential risks to further enhance device performance and optimize its clinical utility.
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Sun et al. (2025) conducted an observational in Mitral regurgitation (n=8,941). MitraClip (transcatheter edge-to-edge repair) vs. Historical comparison (trend over time) was evaluated on Proportion of fatal events relative to all casualty events annually (p=<0.0001). The proportion of fatal events associated with MitraClip implantation among all reported casualties declined significantly from 15.9% in 2014-2015 to 3.5% in 2020-2021.
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