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 Whitlock R.P. Belley-Cote E.P. Paparella D. et al. Left atrial appendage occlusion during cardiac surgery to prevent stroke. N Engl J Med. 2021; 384: 2081-2091 Crossref PubMed Scopus (96) Google Scholar , 2 Makati K.J. Sood N. Lee L.S. et al. Combined epicardial and endocardial ablation for atrial fibrillation: best practices and guide to hybrid convergent procedures. Heart Rhythm. 2021; 18: 303-312 Abstract Full Text Full Text PDF Scopus (8) Google Scholar , 3 Branzoli S. Marini M. Guarracini F. et al. Epicardial standalone left atrial appendage clipping for prevention of ischemic stroke in patients with atrial fibrillation contraindicated for oral anticoagulation. J Cardiovasc Electrophysiol. 2020; 31: 2187-2191 Crossref PubMed Scopus (11) Google Scholar 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.