Coronary Drug-Eluting Stent Complications Using the MAUDE Database
Author(s)
Deeksha S, PharmD1, Ajoshson John, PharmD2, Adusumilli Pramod Kumar, Ph.D3, JEESA GEORGE, M Pharm3.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bengaluru, India, 3M S Ramaiah University Of Applied Sciences, Bangalore, India.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bengaluru, India, 3M S Ramaiah University Of Applied Sciences, Bangalore, India.
OBJECTIVES: Coronary drug-eluting stents (DES) are used to treat coronary artery disease by maintaining arterial patency and minimizing restenosis through localized drug delivery. While clinically effective, DES may be associated with adverse device- and patient-related outcomes. This study aims to assess and characterize adverse events related to DES as reported in the MAUDE (Manufacturer and User Facility Device Experience) database, with emphasis on device performance, patient impact, and reporting trends.
METHODS: A retrospective analysis was performed on MAUDE reports submitted between January 1, 2020, and November 1, 2024. Reports involving coronary DES were extracted and analyzed for device malfunctions, patient complications, demographic data, and geographic origin. Descriptive statistics were used to summarize findings and identify reporting patterns.
RESULTS: A total of 2,500 adverse event reports were reviewed. The most frequently reported device-related issues were “Adverse Event Without Identified Device or Use Problem” (776/2,500) and “Material Deformation” (677/2,500). Among patient-related outcomes, “No Clinical Signs, Symptoms, or Conditions” was reported in 1,325 cases, and “Vascular Dissection” in 310 cases. The SYNERGY brand was cited in 345 reports—the highest among all stent types. Reports were more common in male patients (735) than female patients (238), with the 61-70 age group representing the highest incidence (310), followed by ages 71-80 (221). Geographic analysis showed the United States (468) and India (441) as top reporting countries. A total of 2,123 procedures were performed by healthcare professionals.
CONCLUSIONS: The findings indicate a substantial number of adverse events associated with coronary DES, particularly related to material deformation and vascular complications. These data support the need for ongoing post-market monitoring, improved operator training, and evidence-based strategies to optimize stent safety and performance.
METHODS: A retrospective analysis was performed on MAUDE reports submitted between January 1, 2020, and November 1, 2024. Reports involving coronary DES were extracted and analyzed for device malfunctions, patient complications, demographic data, and geographic origin. Descriptive statistics were used to summarize findings and identify reporting patterns.
RESULTS: A total of 2,500 adverse event reports were reviewed. The most frequently reported device-related issues were “Adverse Event Without Identified Device or Use Problem” (776/2,500) and “Material Deformation” (677/2,500). Among patient-related outcomes, “No Clinical Signs, Symptoms, or Conditions” was reported in 1,325 cases, and “Vascular Dissection” in 310 cases. The SYNERGY brand was cited in 345 reports—the highest among all stent types. Reports were more common in male patients (735) than female patients (238), with the 61-70 age group representing the highest incidence (310), followed by ages 71-80 (221). Geographic analysis showed the United States (468) and India (441) as top reporting countries. A total of 2,123 procedures were performed by healthcare professionals.
CONCLUSIONS: The findings indicate a substantial number of adverse events associated with coronary DES, particularly related to material deformation and vascular complications. These data support the need for ongoing post-market monitoring, improved operator training, and evidence-based strategies to optimize stent safety and performance.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD45
Topic
Clinical Outcomes, Epidemiology & Public Health, Real World Data & Information Systems
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Injury & Trauma, No Additional Disease & Conditions/Specialized Treatment Areas