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Postapproval safety profile of Watchman FLX left atrial appendage occlusion device: Analysis from the MAUDE database

Published:October 19, 2021DOI:https://doi.org/10.1016/j.hrthm.2021.10.015
      Left atrial appendage serves as a major nidus for thrombus formation and subsequent embolization in nonvalvular atrial fibrillation. While traditional oral anticoagulation (OAC) remains the mainstay of treatment to prevent thromboembolism in atrial fibrillation, it is associated with several adverse events such as bleeding, narrow therapeutic window, drug-drug interactions, and poor patient compliance. Percutaneous left atrial appendage occlusion is a viable alternative in patients deemed high risk for thromboembolic and bleeding complications. The second-generation Watchman FLX device (Boston Scientific, Marlborough, MA) is the novel left atrial appendage occlusion device with significant design changes as compared with its predecessor
      • Garg J.
      • Shah K.
      • Shah S.
      • Turagam M.K.
      • Natale A.
      • Lakkireddy D.
      Left atrial appendage occlusion with new Watchman-FLX device.
      —recently approved by Food and Drug Administration (FDA) for commercial use. In this context, we queried the FDA Manufacturer and User Facility Device Experience (MAUDE) database to study the safety profile and assess types of complications with this relatively novel device technology.

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      References

        • Garg J.
        • Shah K.
        • Shah S.
        • Turagam M.K.
        • Natale A.
        • Lakkireddy D.
        Left atrial appendage occlusion with new Watchman-FLX device.
        Am J Cardiol. 2021; 154: 135-137
      1. MAUDE – Manufacturer and User Facility Device Experience. U.S. Food & Drug Administration website.