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Medtronic Voluntarily Recalls Unused Valiant Navion Thoracic Stent Graft System

Medtronic plc (MDT) said Wednesday it has voluntarily issued a global recall of unused Medtronic Valiant Navion thoracic stent graft system and also informed physicians to immediately stop use of the device until further notice.

Medtronic initiated this action after information recently obtained from the Valiant Evo Global Clinical Trial indicated 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. Upon further analysis of the images, 7 out of 87 patients were observed to have stent ring enlargement beyond the design specification.

Medtronic noted that the observations require further assessment to determine potential clinical importance.

Medtronic is currently conducting a comprehensive technical root cause investigation, including further review of follow-up clinical trial imaging and commercial complaints and imaging.

Medtronic said it has contacted the U.S. Food and Drug Administration or FDA, along with other regulatory bodies around the world, to share information related to this issue. The company added it will continue working directly with regulatory authorities on this global voluntary recall.

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