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February 17, 2021
Medtronic Recalls Valiant Navion Thoracic Stent Graft System
February 17, 2021—Medtronic has announced the voluntary recall of its Valiant Navion thoracic stent graft system due to concerns related to stent fractures and stent ring enlargement observed during clinical trial follow-up. Physicians should immediately cease using the device until further notice. The recall affects unused products, but imaging of past implants should also be reviewed with specific attention to stent fractures and type IIIb endoleaks.
In accordance with its commitment to patient safety—and in consultation with independent physicians—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. Those observations require further assessment to determine potential clinical importance.
The company has informed global regulatory bodies of the issue, and a comprehensive root cause investigation is underway, including review of follow-up imaging from the clinical trial as well as commercial complaints and imaging.
Medtronic says that physicians should retrospectively review all available images of patients who were treated with the Valiant Navion system with specific attention to stent fractures and type IIIb endoleaks and contact the company if findings are observed. The company urges physicians to follow best clinical practices and evaluate patients with at least annual follow-up according to the imaging recoommendations in the device's Instructions for Use (IFU).
“There is nothing more important than the safety and well-being of patients,” commented Nina Goodheart, senior vice president and president, Structural Heart & Aortic, in the company's announcement. “We treat matters of product safety with the highest priority and urgency. Our decision to implement this voluntary recall is necessary to ensure the utmost patient safety. As our investigation continues, we are committed to timely communication with physicians and regulatory bodies.”
Medtronic advises that patients with Valiant Navion stent grafts to consult their physicians with any questions.
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