The Food and Drug Administration (FDA) has announced a Class I recall of the Medtronic Valiant Navion Thoracic Stent Graft System due to stent fractures and endoleak concerns.
The Valiant Navion Thoracic Stent Graft System is designed to repair lesions of the descending thoracic aorta using a catheter to place the stent graft. Once placed, the stent expands to fit within the aorta to provide a new path for blood to flow from the heart to the lower part of the body. Medtronic is recalling the Valiant Navion Thoracic Stent Graft System due to stent fractures and endoleak concerns. Following device implantation, patients may experience stent ring enlargement beyond design specification, stent fractures, holes in the graft fabric (Type III endoleaks), life-threatening bleeding, aortic rupture, or death.
The FDA has identified this as a Class I recall, the most serious type of recall, as use of the device may result in serious injury or death. There have been 11 reported issues related to this device, including 2 injuries and 1 death. There have been 4 cases of Type III endoleak, 4 cases of stent fracture, and 7 cases of stent ring enlargement. Some patients experienced multiple findings. Medtronic initially announced this as a voluntary recall in February 2021.
Food and Drug Administration (FDA). Medtronic Recalls Valiant Navion Thoracic Stent Graft System Due to Risk of Stent Fractures and Type III Endoleaks [news release]. April 9, 2021. Available at: click here. Accessed April 9, 2021.