Abstract 4369278: Real-World Adverse Events of the Aurora Extravascular Implantable Cardiac Defibrillator: Insights from the United States FDA MAUDE Registry

Abstract

Introduction: Extravascular implantable cardioverter defibrillators (EV-ICD) utilize a substernal lead to provide the benefits of ICDs without associated vascular risks. Only a few currently exist, and one such is the Aurora EV-ICD TM (Medtronic, Minneapolis, MN). Device-related, real-world complication data remains limited. Objectives: We reviewed the United States Food and Drug Manufacturer and User Facility Device Experience (MAUDE) database for adverse events involving the Aurora EV-ICD. Methods: The MAUDE database is a real-world registry of device-related adverse events. We reviewed this on 6/4/2025 for all events since 10/1/2023 – shortly after it was approved for use. Duplicate reports were removed, and adverse events and device issues were categorized and analyzed. Results: A total of 215 reports were identified, with an average age of 48.3±16.8 years and 75.0% male gender. Adverse events were analyzed as device- and patient-related. The most common device problem was sensing issues (40.4%), which included over- (11.1%) and under-sensing (2.3%); adverse events without an identified problem also occurred frequently (30.7%). The most common patient events occurred without clinical signs or symptoms (35.3%) but were followed by infection (37.3%) and inappropriate shocks (24.7%). This resulted in injury in 77.7% of cases, with death occurring in rare (1.9%) cases. Conclusion: EV-ICDs are an alternative defibrillator option but have shown notable early challenges, including frequent sensing issues, inappropriate shocks, and a high rate of infections. These findings underscore the need for careful patient selection and follow-up. However, the reliance on the MAUDE limits generalizability, and further studies are needed to evaluate its safety and efficacy.