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Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft System

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 importance.

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Medtronic Recalls Unused Valiant Navion Thoracic Stent Grafts

Medtronic Recalls Unused Valiant Navion Thoracic Stent Grafts
Physicians directed to immediately cease use of the Medtronic Valiant Navion thoracic stent graft system
February 23, 2021 — Medtronic 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 these stent fractures resulted in confirmed type IIIb endoleaks. One patient death was reported, the company said.

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Medtronic Voluntarily Recalls Unused Valiant Navion Thoracic Stent Graft System

FRIDLEY (dpa-AFX) - 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

Drug-administration , Medtronic , Medtronic-valiant-navion , Valiant-evo-global-clinical-trial , Valiant-evo-global-clinical , Voluntarily , Recalls , Unused , Valiant , Navion , Thoracic