title: Transcatheter device closure of atrial septal defects: a safety review.
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.
authors.affiliation: Department of Pediatrics, Division of Cardiology, Rady Children's Hospital, University of California, San Diego, San Diego, California 92123, USA. jmoore@rchsd.org
authors.forename: John
authors.initials: J
authors.lastname: Moore
authors.forename: Sanjeet
authors.initials: S
authors.lastname: Hegde
authors.forename: Howaida
authors.initials: H
authors.lastname: El-Said
authors.forename: Robert
authors.initials: R
authors.lastname: Beekman
authors.forename: Lee
authors.initials: L
authors.lastname: Benson
authors.forename: Lisa
authors.initials: L
authors.lastname: Bergersen
authors.forename: Ralf
authors.initials: R
authors.lastname: Holzer
authors.forename: Kathy
authors.initials: K
authors.lastname: Jenkins
authors.forename: Richard
authors.initials: R
authors.lastname: Ringel
authors.forename: Jonathan
authors.initials: J
authors.lastname: Rome
authors.forename: Robert
authors.initials: R
authors.lastname: Vincent
authors.forename: Gerard
authors.initials: G
authors.lastname: Martin
mesh_terms: D001145:Arrhythmias, Cardiac / Q000209:etiology; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation* / Q000592:standards; D018795:Device Approval; D005548:Foreign-Body Migration / Q000209:etiology; D006344:Heart Septal Defects, Atrial / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology; D017410:Practice Guidelines as Topic; D011358:Product Surveillance, Postmarketing; D011474:Prosthesis Design; D011475:Prosthesis Failure; D016459:Prosthesis-Related Infections / Q000209:etiology; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D055989:Septal Occluder Device / Q000592:standards; D013923:Thromboembolism / Q000209:etiology; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration