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Adverse event reporting and regulatory analysis of pediatric cardiac assist devices
Songyining Ding1, Susmitha Wunnava2, Gaite Liu3
1School of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai, China.
Insights
Pediatric cardiac assist device complications are higher than adults, but data is limited. New monitoring systems are needed for better pediatric device safety and risk assessment.
Area of Science:
- Biomedical Engineering
- Pediatric Cardiology
- Regulatory Science
Background:
- Pediatric cardiac assist devices have higher complication rates than adult devices due to anatomical, coagulation, and neurodevelopmental differences.
- Existing adult data is insufficient for pediatric use, and current device supervision processes have deficiencies.
Purpose of the Study:
- To analyze the spectrum of pediatric complications associated with cardiac assist devices.
- To compare pediatric and adult adverse event data from the FDA MAUDE database.
- To identify limitations in traditional databases and reveal regulatory loopholes for pediatric devices.
Main Methods:
- Extracted and analyzed 280 pediatric and 1,231 adult adverse events from the FDA MAUDE database (2015-2025).
- Systematically analyzed the pediatric complication spectrum and compared it with adult data.
- Utilized literature review and case analysis to highlight database limitations and regulatory gaps.
Main Results:
- Pediatric adverse event reports in MAUDE are scarce with missing variables, preventing incidence rate calculation.
- The study highlights the need for a multi-source, real-time monitoring and pediatric-exclusive registration system.
- Preliminary risk assessment and hypothesis generation for pediatric mechanical circulatory support are called for.
Conclusions:
- The study reveals reporting trend disparities between pediatric and adult cohorts using passive surveillance data.
- Findings serve as a reference for future prospective evaluations and standard optimizations.
- Immediate, broad regulatory mandates are not advised due to data constraints.
Background:
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.
Method:
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.
Result:
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.
Conclusion:
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.
