Adverse event reporting and regulatory analysis of pediatric cardiac assist devices.

Abstract

Due to differences in anatomy, coagulation and neurodevelopment, the complication rate of pediatric cardiac assist devices during use is much higher than that of adults, which cannot be directly extrapolated from adult data. Moreover, there are deficiencies in the device supervision process. In this study, 280 adverse events of patients under 18 years old and 1,231 adverse events of adult patients were extracted from the FDA MAUDE database from 2015 to 2025. The pediatric complication spectrum was systematically analyzed, and adult data was compared with pediatric data. Combined with literature and typical case analysis, the limitations of traditional databases were jointly revealed. Finally, in accordance with the existing testing standards, the risks exposed after the product is launched on the market are summarized and the regulatory loopholes are revealed. MAUDE pediatric reports are scarce and variables are missing, making it impossible to directly calculate the incidence rate. The research calls for the establishment of a multi-source real-time monitoring and pediatric exclusive registration system to preliminarily assess and generate hypotheses regarding the risk of mechanical circulatory support in children. This study provides a descriptive evaluation of reporting trend disparities between pediatric and adult cohorts. Given the inherent constraints of passive surveillance data, these exploratory findings should be interpreted as a reference to guide future prospective evaluations and standard optimizations, rather than immediate, broad regulatory mandates.