Wire fractures in Solysafe septal occluders: a single center experience.

OBJECTIVES: To determine the incidence of device fractures (DF) after implantation of a Solysafe Septal Occluder (iSSO) and to assess the spectrum of associated problems.

BACKGROUND: In August 2010, after initial unpublished reports on DF, the manufacturer issued an "urgent field safety notice," prompting all medical care providers to re-examine all patients after iSSO.

METHODS: Prospective single center study. Extended follow-up examination, including standardized fluoroscopy (sF), was performed in all patients after iSSO.

RESULTS: A total of 111 patients had undergone iSSO at our institution between June 2005 and July 2010. Median age and body weight were 50 years (9.3-79.6) and 75 kg (29-122), respectively. Indications for iSSO were (1) patent foramen ovale in patients with a history of cryptogenic stroke (n = 84; 76%) and (2) hemodynamically significant atrial septal defect of the secundum type (n = 27; 24%). A total of 113 devices were implanted. Complete follow-up was available in 103 patients (92.8%). Median follow-up was 1.9 years (0-5.2). There were no postimplantation neurological events or symptoms. The closure rate was 97.1%. DF was suspected on a chest X-ray in one patient and documented in 10 patients by sF. The overall probability of freedom from DF was 82.3% after 5 years. One patient had embolization of a device fragment to the right pulmonary artery. So far, all patients with DF have been managed conservatively.

CONCLUSIONS: The incidence of DF after iSSO is unacceptably high. sF is imperative for accurate diagnosis of DF. Further, follow-up is needed to determine the risk of clinical complications and to optimize management.