WATCHMAN Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Left Atrial Appendage Closure · First cleared Mar 2015

Total Reports

3,797

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Literature Batch: Peri-Device Leak Analysis

data, terms, article, occurred, event terms

reports

Device Migration with Peri-Device Leak

performed watchman, leak, closure procedure, procedure performed, occurred

reports

CVA Post-Implant After Four Years

device implanted, stroke, closure procedure, occurred, discharged

reports

Device Related Thrombus Detected

related, reported occurred, complications, thrombus, imaging

reports

Patient Death During Recovery

complications, effusion, occurred, access, death

reports

Pericardial Effusion During Procedure

wds, pericardial effusion, pericardial, effusion, occurred

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Disproportionate reportinghighIncreasing trendcritical

Evidence

Related research

Watchman device migration and embolization: A report from the NCDR LAAO Registry

Daniel J. Friedman, et al. · Journal of Cardiovascular Electrophysiology · 2023

Contemporary procedural trends of Watchman percutaneous left atrial appendage occlusion in the United States

Muhammad Bilal Munir, et al. · Journal of Cardiovascular Electrophysiology · 2020

Intracardiac echocardiography‐guided implantation of the Watchman FLX left atrial appendage closure device

Mohit K. Turagam, et al. · Journal of Cardiovascular Electrophysiology · 2021

Utilization and procedural adverse outcomes associated with Watchman device implantation

Fouad Khalil, et al. · EP Europace · 2020

Impact of conscious sedation and general anesthesia on periprocedural outcomes in Watchman left atrial appendage closure

Caroline Kleinecke, et al. · Cardiology Journal · 2021

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.