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Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft System FRIDLEY (dpa-AFX) - Medtronic plc has recalled unused Medtronic Valiant Navion thoracic stent graft system globally, according to the U.S. Food and Drug Administration. The Irish medical technology company also informed physicians to immediately cease use of the device until further notice. The company initiated the recall following information obtained from the Valiant Evo Global Clinical Trial indicating that three patients in the trial were observed to have stent fractures, two of which have confirmed type IIIb endoleaks. One patient death was reported. Following these observations, an independent imaging laboratory reviewed all available images from patients enrolled in the Valiant Evo Global Clinical Trial. It was found that 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 import

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