The Food and Drug Administration (FDA) has announced a voluntary recall of unused Medtronic Valiant Navion thoracic stent graft systems.
The Valiant Navion thoracic stent graft system is indicated for the endovascular repair of all lesions of the descending thoracic aorta (DTA) in certain patients. Medtronic initiated the recall in response to information recently obtained from the Valiant Evo Global Clinical Trial indicating that 3 patients in the trial were observed to have stent fractures, 2 of which have confirmed type IIIb endoleaks. One patient death was reported. Medtronic is currently conducting a comprehensive technical root cause investigation, including further review of follow-up clinical trial imaging and commercial complaints and imaging.
Food and Drug Administration (FDA). Medtronic Announces Voluntary Recall of Unused Valiant Navion™ Thoracic Stent Graft System [news release]. February 23, 2021. Available at: click here. Accessed February 24, 2021