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Medtronic Plc (NYSE: MDT) has announced a voluntary global recall of its Valiant Navion thoracic stent graft system after a patient death was reported in a clinical trial. The company has informed physicians to cease use until further notice.
In addition to the single fatality, three patients in the Valiant Evo Global Clinical Trial were observed to have stent fractures, two of which were Type IIIb endoleaks, an uncommon but severe complication of endovascular aortic aneurysm repair.
Further analysis of the images, seven out of 87 patients were observed to have stent ring enlargement beyond the design specification.
In October 2018, the FDA had approved Medtronic's Valiant Navion system for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms.
The Valiant Evo prospective, nonrandomized, single-arm trial seeks to demonstrate the safety and efficacy of the stent-graft system in patients with a descending thoracic aortic aneurysm who are candidates for endovascular repair.
Price Action: MDT stock is down 1.42% at $117.99 in market trading hours on last check Wednesday.
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