Real-World Experience of the Sentinel Cerebral Protection Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database.
Real-World Experience of the Sentinel Cerebral Protection Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database.
- 2020
Available in print through MWHC library: 2002 - present
BACKGROUND/PURPOSE: The 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. CONCLUSIONS: Our 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. Copyright (c) 2019. Published by Elsevier Inc. METHODS/MATERIALS: We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from 2017 through 2019, yielding 43 reports. RESULTS: Of 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).
English
1878-0938
10.1016/j.carrev.2019.11.014 [doi] S1553-8389(19)30760-2 [pii]
*Device Approval
*Embolic Protection Devices
*Intracranial Embolism/pc [Prevention & Control]
*Product Surveillance, Postmarketing
*Stroke/pc [Prevention & Control]
*Transcatheter Aortic Valve Replacement/is [Instrumentation]
*United States Food and Drug Administration
Databases, Factual
Humans
Intracranial Embolism/dg [Diagnostic Imaging]
Intracranial Embolism/et [Etiology]
Intracranial Embolism/mo [Mortality]
Patient Safety
Prosthesis Design
Risk Assessment
Risk Factors
Stroke/dg [Diagnostic Imaging]
Stroke/et [Etiology]
Stroke/mo [Mortality]
Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
Transcatheter Aortic Valve Replacement/mo [Mortality]
Treatment Outcome
United States
MedStar Heart & Vascular Institute
Journal Article
Available in print through MWHC library: 2002 - present
BACKGROUND/PURPOSE: The 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. CONCLUSIONS: Our 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. Copyright (c) 2019. Published by Elsevier Inc. METHODS/MATERIALS: We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from 2017 through 2019, yielding 43 reports. RESULTS: Of 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).
English
1878-0938
10.1016/j.carrev.2019.11.014 [doi] S1553-8389(19)30760-2 [pii]
*Device Approval
*Embolic Protection Devices
*Intracranial Embolism/pc [Prevention & Control]
*Product Surveillance, Postmarketing
*Stroke/pc [Prevention & Control]
*Transcatheter Aortic Valve Replacement/is [Instrumentation]
*United States Food and Drug Administration
Databases, Factual
Humans
Intracranial Embolism/dg [Diagnostic Imaging]
Intracranial Embolism/et [Etiology]
Intracranial Embolism/mo [Mortality]
Patient Safety
Prosthesis Design
Risk Assessment
Risk Factors
Stroke/dg [Diagnostic Imaging]
Stroke/et [Etiology]
Stroke/mo [Mortality]
Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
Transcatheter Aortic Valve Replacement/mo [Mortality]
Treatment Outcome
United States
MedStar Heart & Vascular Institute
Journal Article