February 17, 2021 – Medtronic plc (Dublin, Ireland) has voluntarily issued a global recall of unused Medtronic Valiant Navion thoracic stent graft system and informed physicians to immediately cease use of the device until further notice.
Medtronic initiated this action in response to information recently obtained from the Valiant Evo Global Clinical Trial indicating that three patients in the Valiant Evo Global Clinical 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, seven (7) out of 87 patients were observed to have stent ring enlargement beyond the design specification.
The company says those observations require further assessment to determine potential clinical importance.
Medtronic says it is currently conducting a comprehensive technical root cause investigation, including further review of follow-up clinical trial imaging and commercial complaints and imaging.
Medtronic has contacted the U.S. Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this issue. Medtronic will continue working directly with regulatory authorities on this global voluntary recall.