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In August 2010, after initial unpublished reports on DF, the manufacturer issued an "urgent field safety notice," prompting all medical care providers to re-examine all patients after iSSO.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