Analysis of Neurovascular Device Adverse Events over a Decade: A MAUDE Database Study
Joshua Jimenez1, Chance Swanson1, Liam Devlin1, Gavin Glick1, Aayush Patel1, Rebecca Waite1, Luke Fischbach1, Alexandra Penney1, Maya Wallace1, Joao Victor Sanders2, Marion Oliver2, Krishna Joshi2, Demetrius Lopes2
1Thomas F. Frist, Jr. College of Medicine, 2Brain & Spine Institute, Advocate Health
Objective:
To characterize demographic, device type, and reported event trends in MAUDE reports for intracranial coils, stents, flow diverters, and WEB between 2015-2025.
Background:
Neurointerventional implants have rapidly been introduced over the past decade. A comprehensive cross-device comparison may help distinguish signal patterns from reporting drift, guiding clinician decision making.
Design/Methods:
Device families (coils, stents, flow diverters, WEB) were analyzed in the FDA MAUDE database between 2015-2025. Reports were deduplicated, and demographics and event types were standardized. Data analysis included Spearman correlations, χ2 tests, and Kruskal Wallis for trends in time, distribution, and age respectively. Significance was set at α=0.05.
Results:
18,605 reports were analyzed, comprising 7,602 flow diverters, 6,651 coils, 3,741 stents, and 611 WEB. Reports for flow diverters increased significantly (rho=0.82, p=0.002), stents (rho=0.64, p=0.035), and WEB (rho=0.94, p<0.001), while coils decreased (rho=-0.85, p=0.001). Flow diverter malfunction reports increased numerically over time, with deaths increasing from 12 to 45 from 2018 to 2023 (rho=0.41, p=0.21). WEB reports showed greater clinical severity despite fewer reports, with injury/death comprising 65.8% of reports vs 31.2%, 27.3%, and 21.9% for flow diverters, stents, and coils respectively. Event type distributions differed significantly (global χ2<0.001). Age and event type associations were statistically significant (Kruskal p<0.001). Sex and event type were associated (χ2<0.05). Death odds did not differ by sex.
Conclusions:
Within the last decade, MAUDE reports have increased year over year for flow diverters, stents, and WEB, but decreased for intracranial coils. Flow diverters malfunctions have increased significantly with an increase in reported deaths, and WEB has fewer reports with recent FDA approval in 2019, but a higher proportion of clinically severe events. Device surveillance data can support clinicians, patients, and trainees for post-market signaling and risk counseling.
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