A safety issue observed during a global clinical trial has prompted Medtronic to issue a global recall of unused Valiant Navion thoracic stent graft systems. In the interest of patient safety, the company has told physicians to immediately stop using the device until further notice.
Medtronic said three patients in the Valiant Evo trial were observed to have stent fractures. Two of those patients have confirmed type IIIb endoleaks, and one patient has died.
Following these observations, an independent imaging laboratory reviewed all available images from patients enrolled in the trial. Upon further analysis of the images, 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, the company said.
Medtronic is conducting a comprehensive technical root cause investigation, including further review of follow-up clinical trial imaging and commercial complaints and imaging.
“There is nothing more important than the safety and well-being of patients,” said Nina Goodheart, senior vice president and president of Medtronic's structural heart and aortic business, which is reported as part of the company's cardiac vascular group. “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 has contacted FDA, along with other regulatory bodies around the world, to share information related to this issue. Patients with a Medtronic Valiant Navion thoracic stent graft system should consult their physician with any questions.
As part of the voluntary recall of unused product, 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 has 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 contact Medtronic if any imaging findings are observed. The Dublin, Ireland-based company also urged physicians to follow best clinical practices and evaluate patients with at least annual follow-up according to the imaging recommendations in the instructions for use for the device.