Abstract
This review discusses the current safety issues related to U.S. Food and Drug Administration approved atrial septal defect devices and proposes a potential avenue to gather additional safety data including factors, which may be involved in device erosion.
Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
MeSH terms
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Arrhythmias, Cardiac / etiology
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Cardiac Catheterization / adverse effects*
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Cardiac Catheterization / instrumentation*
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Cardiac Catheterization / standards
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Device Approval
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Foreign-Body Migration / etiology
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Heart Septal Defects, Atrial / diagnosis
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Heart Septal Defects, Atrial / therapy*
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Humans
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Hypersensitivity / etiology
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Practice Guidelines as Topic
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Product Surveillance, Postmarketing
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Prosthesis Design
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Prosthesis Failure
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Prosthesis-Related Infections / etiology
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Registries
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Risk Assessment
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Risk Factors
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Septal Occluder Device* / standards
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Thromboembolism / etiology
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Treatment Outcome
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United States
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United States Food and Drug Administration
Supplementary concepts
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Atrial Septal Defect, Secundum Type