title: Delayed spontaneous perforation of polyvinyl alcohol membrane-Covered atrial septal defect closure devices.
abstract: Percutaneous device closure has become the first choice for secundum atrial septal defect (ASD) closure when feasible in case of favorable anatomy. The Ultrasept II ASD occluder® device (Cardia Inc, Eagan, MN) is made of two nitinol disc frames covered with polyvinyl alcohol membranes, a synthetic polymer with a large application in the biomedical field. Four relatively early malfunctions of the polyvinyl alcohol membrane were observed in a series of six consecutive patients treated with ASD Ultrasept II closure device in our institution. Operators have to be aware of this apparently rare complication that is likely to be underestimated, associated with such devices. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Cardiology, CHU De Caen, Caen, F-14000, France.
authors.forename: Fabien
authors.initials: F
authors.lastname: Labombarda
authors.affiliation: Department of Cardiology, CHU De Caen, Caen, F-14000, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Roule
authors.affiliation: Department of Cardiology, CHU De Caen, Caen, F-14000, France.
authors.forename: Farzin
authors.initials: F
authors.lastname: Beygui
mesh_terms: D000328:Adult; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000379:methods*; D006348:Cardiac Surgical Procedures / Q000379:methods*; D020099:Coated Materials, Biocompatible; D017548:Echocardiography, Transesophageal; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000175:diagnosis / Q000601:surgery*; D006801:Humans; D008297:Male; D011142:Polyvinyl Alcohol; D011474:Prosthesis Design; D011475:Prosthesis Failure; D055989:Septal Occluder Device / Q000009:adverse effects*; D000072663:Spontaneous Perforation; D013997:Time Factors; D055815:Young Adult
chemical_list: D020099:Coated Materials, Biocompatible; D011142:Polyvinyl Alcohol
keywords: ASD device; complication; perforation