Medtronic has launched a global recall of its Valiant Navion thoracic stent graft system, used to reinforce large blood vessels at risk of rupturing from an aneurysm or other injuries.
The medtech giant notified physicians to cease using the implant until further notice, following reports of three stent fractures and the death of one patient in an international clinical trial of the device.
The Valiant system is designed to fortify a weakened aorta from the inside and relieve the pressure on the vessel’s walls. The device is threaded through the body’s arteries via a minimally invasive catheter procedure to avoid open surgery and deploys a synthetic fabric tube supported by a metal stent scaffold.
According to Medtronic, two of the three stent fractures resulted in confirmed tears in the fabric tube, leaking blood out of the implant’s channel.
In addition, patient imaging scans found that the stents in seven of the study’s 87 participants had widened to a diameter beyond the implant’s design specifications. The company said those cases need further evaluation to determine potential clinical effects, and it is currently conducting technical root cause investigations and reviewing follow-up trial imaging and commercial complaints.
“There is nothing more important than the safety and well-being of patients,” Nina Goodheart, president of Medtronic’s structural heart and aortic business, said in a statement. “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.”