Key result
Amplatzer Amulet linked to ~2.8-fold higher odds of thromboembolic events vs Watchman FLX.
Why the study?
While randomized trials demonstrate similar efficacy for current-generation left atrial appendage occlusion (LAAO) devices, their real-world complication patterns may differ.
Does the Amplatzer Amulet have a different real-world adverse event profile compared to the Watchman FLX family in FDA MAUDE reports?
Observational (n=8,406)
Does the Amplatzer Amulet have a different real-world adverse event profile compared to the Watchman FLX family in FDA MAUDE reports?
Analysis of 8,406 FDA MAUDE adverse event reports reveals distinct real-world complication patterns between contemporary Watchman FLX and Amplatzer Amulet LAAO devices, with higher proportions of pericardial, thromboembolic, and fatal procedural events reported among Amulet cases.
Higher reported Amulet events in MAUDE data warrant cautious interpretation; leaves open true incidence differences versus Watchman FLX.
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.
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Abdelsayed et al. (2026) conducted an observational in Non-valvular atrial fibrillation undergoing left atrial appendage occlusion (n=8,406). Amplatzer Amulet vs. Watchman FLX family (FLX and FLX Pro) was evaluated on Thromboembolic events (OR 2.83). Amplatzer Amulet had higher reported proportions of pericardial complications (40.6% vs 20.0%), thromboembolic events (16.4% vs 5.9%; OR 2.83), and ≤30-day deaths (6.3% vs 3.3%) than Watchman FLX.
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