Real-World Safety and Complications of the Boston Scientific AGENT Drug-Coated Balloon From the FDA MAUDE Database

Drug-coated balloons (DCBs) represent a novel treatment option for coronary in-stent restenosis (ISR). The AGENT DCB (Boston Scientific, Marlborough, MA) demonstrated superior efficacy in treating ISR compared to uncoated balloons in randomized controlled trials. However, real-world data on AGENT DCB safety remains limited.

This study sought out to evaluate post-marketing adverse event reports related to the AGENT DCB.

This study analyzed post-marketing adverse event reports submitted to the FDA Manufacturer and User Facility Device Experience (MAUDE) database between March 1, 2024, and March 1, 2025, specifically focusing on coronary interventions utilizing the AGENT DCB. Reports were independently reviewed and categorized by device-related complications, patient injuries, and device failures. Data were summarized descriptively, and limitations inherent to the MAUDE database were considered.

After screening and excluding duplicates, 155 reports on the AGENT DCB were included. Among all reports, device malfunctions without injury were most common (56.77%), followed by patient injury (30.97%) and death (12.26%). Of the total reported device problems, balloon rupture (33.55%) and shaft breakage (10.32%) were predominant. Injuries reported included angina (32.84%), acute myocardial infarction (29.85%), and coronary perforation (8.95%). Notably, 30 MAUDE reports described off-label treatment of de novo lesions; these off-label cases exhibited similar injury rates compared to ISR-treated lesions (53.33% vs. 57.89%).

Real-world analysis of FDA MAUDE reports revealed frequent device malfunctions, mainly balloon rupture and shaft breakage, and patient complications such as angina, myocardial infarction, and coronary perforation. The off-label use for de novo lesions highlights the need for caution and further clinical investigation.