PATTERNS AND OUTCOMES OF ADVERSE EVENTS ASSOCIATED WITH HYDROCEPHALUS SHUNTS: EVIDENCE FROM THE MAUDE DATABASE
Author(s)
SHEETAL J, Jr., MPH1, JEESA GEORGE, M PHARM2.
1Student, MSRUAS, bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India.
1Student, MSRUAS, bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India.
OBJECTIVES: Hydrocephalus shunts are critical medical devices used to manage cerebrospinal fluid accumulation; however, device-related adverse events (AEs) may lead to significant morbidity and mortality, particularly among pediatric patients. This study aimed to characterize the frequency, patterns, and outcomes of AEs associated with hydrocephalus shunts reported in the U.S. Food and Drug Administration's Manufacturing and User Facility Device Experience (MAUDE) database.
METHODS: A retrospective analysis of adverse event reports associated with hydrocephalus shunts (FDA product code JXG) was conducted using the FDA Manufacturing and User Facility Device Experience (MAUDE) database. Reports submitted between January 1, 2015, and July 10, 2025, were retrieved and analyzed. Data were categorized by event type, device-related problem, patient outcome, reporter type, age group, and geographic region. Descriptive statistics were used to characterize reporting patterns and describe trends across pediatric, adult, and geriatric populations, including temporal and reporter-based analyses.
RESULTS: A total of 13,847 AE reports were documented. Reporting peaked in 2018 (10.7%), 2021 (10.6), and 2022 (9.6%), reflecting fluctuations over time. The United States accounted for highest reports (39.4%), followed by Japan (9.6%) and China (4.3%). Reports were mainly submitted by manufacturers and physicians. Pediatric patients made up the highest share (41.9%), followed by adults (30.2%) and geriatrics (27.9%). Injury was the most common event type (66.6%), followed by malfunctions (28.1%) and deaths (0.88%). Device-related problems included mechanical jam/problem (9.4%), obstruction/occlusion (10.1%), and break (7.7%). Common patient-related problems included failure to implant (4.7%), headache (4.18%), and injury (2.96%).
CONCLUSIONS: Hydrocephalus shunts were associated with substantial numbers of injury- and malfunction-related adverse events, particularly among pediatric patients. Continued post-market surveillance and robust materiovigilance systems are essential to enhance device safety and inform clinical and regulatory decision-making.
METHODS: A retrospective analysis of adverse event reports associated with hydrocephalus shunts (FDA product code JXG) was conducted using the FDA Manufacturing and User Facility Device Experience (MAUDE) database. Reports submitted between January 1, 2015, and July 10, 2025, were retrieved and analyzed. Data were categorized by event type, device-related problem, patient outcome, reporter type, age group, and geographic region. Descriptive statistics were used to characterize reporting patterns and describe trends across pediatric, adult, and geriatric populations, including temporal and reporter-based analyses.
RESULTS: A total of 13,847 AE reports were documented. Reporting peaked in 2018 (10.7%), 2021 (10.6), and 2022 (9.6%), reflecting fluctuations over time. The United States accounted for highest reports (39.4%), followed by Japan (9.6%) and China (4.3%). Reports were mainly submitted by manufacturers and physicians. Pediatric patients made up the highest share (41.9%), followed by adults (30.2%) and geriatrics (27.9%). Injury was the most common event type (66.6%), followed by malfunctions (28.1%) and deaths (0.88%). Device-related problems included mechanical jam/problem (9.4%), obstruction/occlusion (10.1%), and break (7.7%). Common patient-related problems included failure to implant (4.7%), headache (4.18%), and injury (2.96%).
CONCLUSIONS: Hydrocephalus shunts were associated with substantial numbers of injury- and malfunction-related adverse events, particularly among pediatric patients. Continued post-market surveillance and robust materiovigilance systems are essential to enhance device safety and inform clinical and regulatory decision-making.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PT42
Topic
Real World Data & Information Systems
Topic Subcategory
Health & Insurance Records Systems
Disease
Injury & Trauma, Neurological Disorders, Pediatrics, Rare & Orphan Diseases