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Updated: Nov 2, 2025
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
MAUDE Database Analysis of Post-Approval Outcomes following Left Atrial Appendage Closure with the Watchman Device
Pablo A Ledesma1, Uwajachukwumma A Uzomah1, Xuejing Yu1
1Cardiac Arrhythmia Service, MGH Heart Center, Massachusetts General Hospital Heart, Boston, Massachusetts.
Insights
Real-world data shows the Watchman device for left atrial appendage closure (LAAC) has a low adverse event rate, but some serious events like stroke and device embolization occur late after implantation.
Area of Science:
- Cardiology
- Medical Devices
- Patient Safety
Background:
- Left atrial appendage closure (LAAC) using the Watchman device is a key stroke risk reduction strategy for non-valvular atrial fibrillation (AF) patients.
- Real-world safety data for the Watchman LAAC device is limited, necessitating further investigation.
- Patients with AF often have high bleeding risks, making long-term anticoagulation challenging.
Purpose of the Study:
- To assess the frequency and timing of adverse events associated with Watchman LAAC device implants.
- To analyze real-world safety outcomes post-FDA approval of the Watchman device.
Main Methods:
- Utilized the FDA Manufacturer and User Facility Device Experience (MAUDE) database to identify adverse events.
- Analyzed data from March 2015 to March 2019, covering an estimated 43,802 Watchman implants.
- Categorized adverse events by type, timing, and compared rates to clinical trials.
Main Results:
- Identified 3,652 unique adverse events, with an overall rate of 7.3% and mortality of 0.4%.
- Pericardial effusion was the most frequent adverse event (1.4%), with most events occurring intraoperatively or within 1 day.
- A significant proportion of deaths (19%), strokes (24%), and device embolizations (27%) occurred more than 1 month post-implantation.
Conclusions:
- The overall adverse event rates for the Watchman LAAC device are comparable to clinical trial data.
- While most events occur early, late-occurring serious events (stroke, embolization, death) are a concern.
- Continued post-market surveillance is crucial for understanding the long-term safety profile of LAAC devices.
Abstract:
Left atrial appendage closure (LAAC) is an important strategy to reduce stroke risk in patients with non-valvular atrial fibrillation (AF) who are at high risk of bleeding on long-term anticoagulation. Real-world assessments of the safety of the Watchman LAAC device remain limited. 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. During the study period, 3,652 unique adverse events were identified. An estimated 43,802 Watchman implants were performed in the United States during the study period. The overall adverse event rate was 7.3% and the mortality rate was 0.4%. Of the 159 unique types of adverse events identified, pericardial effusion was most common (1.4%). Most adverse events (73%) occurred intraoperatively (59%) or within 1 day of the procedure (15%). However, 19% of deaths, 24% of strokes and 27% of device embolizations occurred >1 month after implantation. The rates of most Watchman-related adverse events reported in the MAUDE database were comparable to those observed in clinical trials. A majority of adverse events occurred within 1 day of implant. In conclusion, while the absolute event rates were low, a significant proportion of device embolizations, strokes, and deaths occurred >1 month after Watchman implant.
