Abstract Details

Title Analysis of Neurovascular Device Adverse Events over a Decade: A MAUDE Database Study

Topic Cerebrovascular Disease and Interventional Neurology

Presentation(s) P6 - Poster Session 6 (5:00 PM-6:00 PM)

Poster/Presentation
Number 4-009

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.

Authors/Disclosures
Joshua Jimenez PRESENTER	Mr. Jimenez has nothing to disclose.
Chance W. Swanson	Mr. Swanson has nothing to disclose.
Liam Devlin, BS	Mr. Devlin has nothing to disclose.
Gavin Glick, Medical student	Mr. Glick has nothing to disclose.
Archis Patel, PharmD	Dr. Patel has nothing to disclose.
Rebecca C. Waite, Medical Student	Ms. Waite has nothing to disclose.
Luke Fischbach, Medical Student	Mr. Fischbach has nothing to disclose.
Alexandra L. Penney	Miss Penney has nothing to disclose.
Maya Wallace	Ms. Wallace has nothing to disclose.
Joao Victor Sanders (Brain & Spine Institute, Advocate Health)	Joao Victor Sanders has nothing to disclose.
Marion Oliver, MD (GRMEP)	Dr. Oliver has nothing to disclose.
Krishna Joshi (Brain & Spine Institute, Advocate Health)	No disclosure on file
Demetrius Lopes (Brain & Spine Institute, Advocate Health)	Demetrius Lopes has nothing to disclose.

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