Real-world complication profiles of left atrial appendage occlusion devices: a MAUDE database analysis of 8,406 adverse events
K Abdelsayed, M T Desouki, A Bahbah, M P Katsiyiannis, D Witt, J Sengupta, R G HauserAbstract
Background
Left atrial appendage occlusion (LAAO) devices reduce stroke risk in patients with non-valvular atrial fibrillation unsuitable for long-term anticoagulation. While randomized trials demonstrate similar efficacy, real-world complication patterns may differ.
Objective
We analyzed the FDA MAUDE database to compare adverse event profiles of current-generation LAAO devices.
Methods
We queried MAUDE adverse event reports (2021–2025) for Watchman FLX family (FLX and FLX Pro) and Amplatzer Amulet. After excluding literature reports, non-manufacturer submissions, and delivery system-only events, we compared complications using chi-square tests. Deaths were limited to procedural events (≤30 days). Rates (%) are the proportion of reports.
Results
The analysis included 8,406 reports: Watchman FLX (n=6,135) and Amulet (n=2,271). A total of 8,406 reports were included (Watchman FLX 6,135; Amulet 2,271). Amulet had substantially higher rates of pericardial complications (40.6% vs 20.0%), driven by higher tamponade (16.1% vs 7.5%) and lower perforation (0.8% vs 2.5%). Thromboembolic events were more frequent with Amulet (16.4% vs 5.9%; OR 2.83), including higher stroke/CVA (5.3% vs 11.2%) and device thrombosis (11.1% vs 24.6%). Device embolization was similar. Procedural deaths ≤30 days were nearly twice as common with Amulet (6.3% vs 3.3%). Key findings are summarized in Table 1.
Conclusion
While true incidence is unknown, MAUDE analysis suggests there are clinically distinct complication profiles for contemporary Watchman and Amulet LAAO devices in real-world use.