title: Partial prolapse of a HELEX device associated with early frame fracture and mitral valve perforation.
abstract: One or more breaks in the wire frame of the HELEX Septal Occluder (W.L. Gore and Associates, Flaggstaff, Arizona) were identified in 5% of patients in the multicenter pivotal trial leading to FDA approval. Fractures of the perimeter frame have not previously been associated with any apparent deleterious clinical effects. We report a case in which the broken ends of wire at a frame fracture were located in a position that resulted in perforation of the anterior mitral valve leaflet. There was significant mitral regurgitation and the device was removed surgically. The possible etiologies and prevention of wire frame fractures are also discussed.
authors.affiliation: Center for Pediatric and Congenital Heart Disease, The Cleveland Clinic, Cleveland, Ohio 44195, USA. quresha@ccf.org
authors.forename: Athar M
authors.initials: AM
authors.lastname: Qureshi
authors.forename: Muhammad A
authors.initials: MA
authors.lastname: Mumtaz
authors.forename: Larry A
authors.initials: LA
authors.lastname: Latson
mesh_terms: D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation; D006348:Cardiac Surgical Procedures; D002648:Child; D020878:Device Removal; D018618:Echocardiography, Doppler, Color; D006344:Heart Septal Defects, Atrial / Q000000981:diagnostic imaging / Q000601:surgery / Q000628:therapy*; D006801:Humans; D008297:Male; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000293:injuries*; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging / Q000209:etiology* / Q000601:surgery; D011474:Prosthesis Design; D011475:Prosthesis Failure; D015641:Radiography, Interventional; D055989:Septal Occluder Device / Q000009:adverse effects*