title: Late presentation of CardioSEAL PFO closure device fracture and thrombus formation three years after device implantation.
abstract: Transcatheter closure of patent foramen ovale (PFO) is a promising alternative to surgical closure or anticoagulation therapy in patients with a history of cryptogenic stroke. Although a number of transcatheter closure devices have been developed and used outside of the United States, the two commonly used devices in the United States are the StarFLEX CardioSEAL and the Amplatzer Occluder. Several complications, both early and late, associated with the devices have been reported in 6-11% of patients. The rates of complication vary with the different devices. Complications include device-related thrombi, embolization, device malposition, fracture, air embolism, arrhythmias, pericardial effusion, need for surgical intervention and death. As reported in the literature, the incidence of longterm complications beyond 1 year is rare. We report a case of a very late presentation of CardioSEAL device arm fracture associated with left atrial thrombus 3 years after device implantation.
authors.affiliation: Division of Cardiology, LAC and USC Medical Center, Los Angeles, California, USA. vnarayan@usc.edu
authors.forename: Vidya
authors.initials: V
authors.lastname: Narayan
authors.forename: Poonam
authors.initials: P
authors.lastname: Puri
authors.forename: Anilkumar O
authors.initials: AO
authors.lastname: Mehra
mesh_terms: D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation; D020878:Device Removal; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications / Q000601:surgery / Q000628:therapy*; D006331:Heart Diseases / Q000209:etiology*; D006801:Humans; D019736:Prostheses and Implants / Q000009:adverse effects; D011475:Prosthesis Failure; D019919:Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation*; D012086:Reoperation; D020521:Stroke / Q000209:etiology; D013927:Thrombosis / Q000209:etiology*; D013997:Time Factors