Medtronic Recalls Valiant Navion Thoracic Stent Graft

Medtronic has recalled all unused Valiant Navion thoracic stent grafts and informed physicians to immediately stop using the device until further notice due to reports from the Valiant Evo Global Clinical Trial indicating that three were observed to have stent fractures, two of which have confirmed Type IIIb endoleaks, and one patient death.

Following the reports, an independent laboratory reviewed all available images from patients enrolled in the trial and determined that seven out of 87 were observed to have stent ring enlargement beyond the design specification, a recall notice says. “Those observations require further assessment to determine potential clinical importance,” it says. “Medtronic is currently conducting a comprehensive technical root cause investigation, including further review of follow-up clinical trial imaging and commercial complaints and imaging."