HAART Aortic Annuloplasty Device

Description of Event or Problem

The manufacturer was informed of an aortic repair involving HAART Annuloplasty Ring from the paper: "Mid-term outcomes after aortic valve repair with the internal geometric annuloplasty ring" by Yujiro Yokoyama, et al. Based on the information provided in the paper, a patient with tricuspid aortic valve with 27-mm annulus and a 56-mm root who underwent valve sparing root remodeling using a 21-mm internal geometric annuloplasty ring and left coronary leaflet plication presented with severe AI, severe mitral regurgitation, and severe tricuspid regurgitation with reduced left ventricular function. Owing to the prohibitive risk of an open procedure, the patient underwent valve-in-ring transcatheter aortic valve replacement. Compared with before and after geometric annuloplasty ring placement on computed tomography, the aortic valve annular size was reduced by approximately 50% by the internal geometric annuloplasty ring. Balloon valvuloplasty of the ringed aortic valve was performed using a 19-mm noncompliant balloon. Subsequently, a 26-mm self-expandable transcatheter valve was deployed. Post-replacement echocardiography revealed no paravalvular leaks. The aortic valve mean gradient was 9 mm Hg. The patient¿s postoperative course was uncomplicated and was discharged home on the fifth postoperative day.

Additional Manufacturer Narrative

Manufacturer is retrieving additional information and device from the healthcare facility through the corresponding author of the paper. A follow-up report will be submitted upon availability of new details and/or the device.