The Food and Drug Administration (FDA) has announced a Class I recall of the Medtronic Valiant Navion™ thoracic stent graft system, which was distributed between November 12, 2018 and February 10, 2021.
The Valiant Navion™ thoracic stent graft system is designed for the endovascular repair of lesions in the descending thoracic aorta. When placed within the aorta, the stent graft provides an alternative path for blood flow within the patient’s vasculature by excluding the lesion from blood flow and pressure.
The recall was initiated due to reports of stent fractures and endoleaks. Thus far, there have been 11 reported issues, including 4 cases of Type III endoleak, 4 cases of stent fracture, and 7 cases of stent ring enlargement; among these reports, there have been 2 injuries and 1 death.
Clinicians should immediately cease using the stent graft system and follow instructions for returning unused product to Medtronic. Additionally, it is recommended that all available images of patients treated with the stent graft system be reviewed. Moreover, any adverse events or product safety issues should be reported to Medtronic.
For more information related to this recall visit medtronic.com.
U.S. Food and Drug Administration. Medtronic recalls Valiant Navion thoracic stent graft system due to risk of stent fractures and Type III endoleaks. https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-valiant-navion-thoracic-stent-graft-system-due-risk-stent-fractures-and-type-iii. Accessed April 9, 2021.