MAUDE Database Analysis of Post-Approval Outcomes following Left Atrial Appendage Closure with the Watchman Device

The objective of this study was to determine the frequency and timing of adverse events associated with Watchman LAAC device implants performed after FDA approval. Adverse events associated with Watchman LAAC implants performed between March 2015 and March 2019 were identified through a search of the FDA Manufacturer and User Facility Device Experience (MAUDE) database.

Source: The American Journal of Cardiology - June 8, 2021 Category: Cardiology Authors: Pablo A. Ledesma, Uwajachukwumma A. Uzomah, Xuejing Yu, Ayman Shaqdan, Pegah Khaloo, Jennifer Galvin, Moussa Mansour, Leon M. Ptaszek, Jeremy N. Ruskin Source Type: research