Medtronic has voluntarily issued a global recall of its Valiant Navion thoracic stent graft system and informed physicians to immediately cease use of the device until further notice.
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 trial were observed to have stent fractures, two of which have confirmed type IIIb endoleaks. One patient death was reported.
Detailing what is known about the patient death and events prior, Medtronic state the following sequence of events: a secondary reintervention was performed to treat the type IIIb endoleak; the patient experienced hypotension three days after the secondary procedure and died; in the absence of an autopsy or explant, the mortality was reported as probable aortic rupture and adjudicated by the trial’s independent Clinical Events Committee as aneurysm-related mortality because it occurred within 30 days of the secondary procedure. Medtronic continues to investigate root causes and potential impact.
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 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.
Medtronic is currently 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, Structural Heart and Aortic, which is reported as part of the Cardiac Vascular Group at Medtronic. “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 the US 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.