Adverse events associated with the AtriClip device for left atrial appendage occlusion: A Food and Drug Administration MAUDE database study

Based on autopsy studies, the left atrial appendage has been implicated as the cause of stroke in>90% of cases with nonvalvular atrial fibrillation. The AtriClip device (Atricure, West Chester, OH) is used for left atrial appendage exclusion at the time of median sternotomy or thoracoscopically (as a  stand-alone procedure or at the time of hybrid epicardial-endocardial ablation for atrial fibrillation).1–3 The real-world safety profile of AtriClip has not been evaluated, and we analyzed adverse events related to its use reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.

Source: Heart Rhythm - April 28, 2022 Category: Cardiology Authors: Tahmeed Contractor, Rahul Bhardwaj, Ravi Mandapati, Kamal Kotak, Jalaj Garg Tags: Research Letter Source Type: research