Medtronic Recalls Valiant Navion Thoracic Stent Graft System Due to Risk of Stent Fractures and Type III Endoleaks
The U.S. Food and Drug Administration has classified the recall of the Medtronic Valiant Navion Thoracic Stent Graft System as a Class I recall. A Class I recall is the most severe type of recall, and it is applied to defective products that may cause injury or death. The recall states that the Medtronic Valiant Navion Thoracic Stent Graft System was distributed from November 12, 2018, to February 10, 2021. The recall affects approximately 14,237 units sold in the United States.
The Valiant Navion Thoracic Stent Graft System was developed to “repair lesions of the descending thoracic aorta, located in the body’s largest artery (aorta) which passes through the lower part of the chest.” The surgical procedure involves the heart surgeon using a long tube-like catheter to place a stent graft inside the patient’s aorta. Once the stent graft has been placed, it expands to fit inside of the aorta and provides a new route for blood to move from the heart to the lower body.
Medtronic issued its Valiant Navion Thoracic Stent Graft System recall because the stent has been reported to fracture and create endoleak concern. After the device has been implanted, some patients have experienced stent ring enlargement exceeding design specifications leading to holes in the graft fabric (Type III endoleaks), stent fractures, life-threatening bleeding, aortic ruptures, or death.
So far, the have been eleven reported complications related to the Valiant Navion Thoracic Stent Graft System, including one death and two injury events. There have been four Type III endoleak incidents, four stent fracture cases, and seven stent ring enlargement cases. A few patients experienced multiple issues.
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