Real-World Experience of the Sentinel Cerebral Protection Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database |
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| Affiliation: | 1. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America;2. Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, United States of America;1. Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California;2. National Heart and Lung Institute, Imperial College London, London, United Kingdom;1. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America;2. Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute National Institutes of Health, Bethesda, MD, United States of America;1. Department of Cardiovascular Medicine, Cleveland Clinic, OH, United States;2. Department of Cardiovascular Medicine, Emory University, GA, United States;3. Division of Cardiology, New York University, NY, United States;4. Department of Cardiothoracic surgery, Cleveland Clinic, OH, United States;5. Department of Cardiovascular Medicine, Cleveland Clinic, Abu Dhabi, United Arab Emirates |
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| Abstract: | Background/purposeThe Sentinel Cerebral Protection System (Boston Scientific, Marlborough, Massachusetts) is indicated for use as a cerebral protection device to capture and remove embolic material during transcatheter aortic valve procedures and was approved by the US Food and Drug Administration (FDA) in 2017. Robust data on the most commonly reported complications and modes of failure associated with the Sentinel device are limited.Methods/materialsWe analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from 2017 through 2019, yielding 43 reports.ResultsOf the 43 reports of major complications involving Sentinel devices, 23 involved either death (3) or injury (20) related to the device. The 3 deaths were due to stroke, while 18 of the 20 injuries were reported as stroke. The other 20 reports were related to device modes of failure. Modes of failure were due to damaged device (5), difficulty retrieving/resheathing the device (5); package contamination (4), difficulty deploying the device (3), and, finally, complications with preparation (3).ConclusionsOur analysis of the MAUDE database demonstrates that in real-world practice, the Sentinel Cerebral Protection System may be associated with complications, including death, stroke, vascular injury, and difficulties with the device itself. The MAUDE database serves as an important tool for both physicians and manufacturers to optimize performance and clinical outcomes. |
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