Amplatzer Amulet Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Left Atrial Appendage Closure · First cleared Apr 2025 · 8 device variants grouped
Total Reports
2,606
Reports (30d)
45
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Pericardial Tamponade at Implant
amulet left, amplatzer amulet, amulet, implant using, amplatzer
66
reports
Literature Batch: Long-Term Death Outcomes
corresponding, included study, disease, group, included
11
reports
Device-Related Thrombosis at Follow-Up
related thrombus, discharged routine, drt, thrombosis occurred, reported thrombosis
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial
Dhanunjaya Lakkireddy, et al. · Journal of the American College of Cardiology · 2024
Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial
Dhanunjaya Lakkireddy, et al. · Circulation · 2021
Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device
Kasper Korsholm, et al. · Journal of Interventional Cardiac Electrophysiology · 2022
Short term outcome after left atrial appendage occlusion with the AMPLATZER Amulet and WATCHMAN device: results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure)
Lucie Kretzler, et al. · BMC Cardiovascular Disorders · 2022
Left Atrial Appendage Occlusion Using the Amplatzer Amulet Device in High-Risk Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Intervention: A Randomized Pilot Study
Philipp Jakob, et al. · Structural Heart · 2025
Citations indexed from PubMed.
Keep exploring
Related devices in Structural
MitraClip
ABBOTT VASCULAR INC. · 18,673 reports
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC · 13,682 reports
Evolut FX
MEDTRONIC, INC. · 13,277 reports
Evolut PRO
MEDTRONIC, INC. · 7,758 reports
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC
Edwards Lifesciences LLC · 6,164 reports
CoreValve Evolut
MEDTRONIC, INC. · 4,432 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
Get Early AccessUnderstanding this data