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Medtronic voluntarily recalls unused Valiant Navion thoracic stent graft system after patient dies in trial

Economy, Finance

Medical device maker Medtronic Plc said Wednesday it is voluntarily recalling unused Valiant Navion thoracic stent graft system and informing doctor to immediately stop using the device until further notice. The company said the move comes after a trial found three patients had stent fractures and one died. An independent imaging laboratory reviewed all images from patients in the trial. “Upon further analysis of the images, seven (7) out of 87 patients were observed to have stent ring enlargement beyond the design specification,” the company said in a statement. “Those observations require further assessment to determine potential clinical importance.” Medtronic shares were down 2.2% premarket, and have gained 2% in the last 12 months, while the S&P 500 has gained 16%.

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