On February 23, 2021, Medtronic plc (Medtronic) announced its voluntary 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 the recall 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.
Medtronic was informed of the two patients in the Valiant Evo Global Clinical Program who were observed to have stent fractures and Type IIIb endoleaks upon review of the two- and three-year follow-up CT images. The first patient event was reported on December 21, 2020 and the second patient event was reported on January 27, 2021. The first patient died following reintervention, and the death was adjudicated by the trial’s Clinical Events Committee as aneurysm-related. The two complaints were reported out of approximately 14,000 patients implanted with Valiant Navion Thoracic Stent Graft globally.
An independent imaging laboratory reviewed all available images from patients enrolled in the Valiant Evo Global Clinical Trial which found that 7 out of 87 patients were observed to have stent ring enlargement beyond the design specification and one stent fracture, requiring further assessment to determine potential clinical importance.
Medtronic has advised patients with a Medtronic Valiant Navion thoracic stent graft system to consult their physician with any questions.
As part of the voluntary recall of unused Medtronic Valiant Navion™ thoracic stent graft system, physicians were sent written communication from Medtronic directing them to immediately cease use of the Medtronic Valiant Navion thoracic stent graft system and instructions for returning unused product to Medtronic. Medtronic advised physicians to retrospectively review all available images of patients treated with Valiant Navion thoracic stent graft system with specific attention to stent fractures and type IIIb endoleaks and to contact Medtronic if any imaging findings are observed, and to evaluate patients with at least annual follow-up according to the imaging recommendations in the Medtronic Valiant Navion thoracic stent graft system Instructions for Use (IFU).
The senior vice president and president, Structural Heart & Aortic, which is reported as part of the Cardiac Vascular Group at Medtronic, stated with respect to the medical device recall, “There is nothing more important than the safety and well-being of patients. 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.”
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