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A safety issue observed during a global clinical trial has prompted Medtronic to issue a global recall of unused Valiant Navion thoracic stent graft systems. In the interest of patient safety, the company has told physicians to immediately stop using the device until further notice. Medtronic said three patients in the Valiant Evo trial were observed to have stent fractures. Two of those patients have confirmed type IIIb endoleaks, and one patient has died. Following these observations, an independent imaging laboratory reviewed all available images from patients enrolled in the trial. Upon further analysis of the images, seven out of 87 patients were observed to have stent ring enlargement beyond the design specification. Those observations require further assessment to determine potential clinical importance, the company said.

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