Medtronic Thoracic Stent Class 1 Recall

FDA has classified as Class 1 a Medtronic recall of all unused Valiant Navion thoracic stent grafts 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,” a recall notice says. There have been 11 reported issues related to the device including two injuries and one death. Four cases of Type III endoleak, four stent facture cases, and seven cases of stent ring enlargement have been reported, it says.

The company says the device is designed to repair lesions of the descending thoracic aorta, which passes through the lower part of the chest. A surgeon uses a catheter to place the stent graft inside the aorta, where it expands to provide a new path for blood to flow from the heart to the lower part of the body.