Abstract
The Valiant Navion (VN) Endograft system (Medtronic, Santa Rosa), originally approved in 2018 for use in the United States for minimally invasive repairs of the descending thoracic aorta, was recalled on February 17, 2021 by the company due to stent fractures and stent ring enlargement observed during the clinical follow-up period. Medtronic reported two patients had confirmed Type IIIB endoleaks and one patient has died. Independent lab review indicated that 8% of patients (seven of 87) had stent ring enlargement beyond device specifications.
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