Medtronic Recalls Valiant Navion™ Thoracic Stent Graft System Following Three Stent Fractures and One Patient Death

Compiled by Keke

Medtronic Recalls Its Valiant Navion Thoracic Stent Graft System Worldwide, Which Is Used to Reinforce Major Blood Vessels at Risk of Rupture Due to Aneurysms or Other Damage.

On February 17, medical technology company Medtronic announced a voluntary global recall of unused Valiant Navion™ Thoracic Stent Graft Systems and notified physicians to immediately cease use of the device until further notice. Meanwhile, Medtronic has contacted the U.S. Food and Drug Administration (FDA) and other regulatory authorities worldwide to share information related to this issue. The company stated that it will continue to work directly with regulators on this global voluntary recall.

According to cases recently observed by this medical technology giant, three patients experienced stent fractures during the Valiant Evo global clinical trial, resulting in one death.

The Valiant system is designed to internally reinforce a weakened aorta and reduce stress on the vessel wall. The device is delivered via a minimally invasive catheter through the patient’s arteries to avoid open surgery, and deploys a synthetic fabric graft supported by a metal stent.

According to Medtronic, in three cases of stent graft fracture, type IIIb endoleak was confirmed in two cases, wherein the fracture caused tearing of the fabric graft, resulting in blood flow through the lumen of the implant.

Following these observations, an independent imaging core laboratory reviewed all available imaging data from patients enrolled in the global Valiant Evo clinical trial. Further analysis of the images revealed that 7 out of 87 patients had stent ring expansion widths exceeding the implant’s design specifications.

Medtronic stated that these cases require further evaluation to determine potential clinical implications, and the company is currently conducting a comprehensive technical root cause investigation, including further review of subsequent clinical trial imaging and commercial complaints.

Nina Goodheart, Senior Vice President of Medtronic and President of the Cardiac and Aortic Structural Business within the Cardiovascular Portfolio, stated in a press release: “Nothing is more important than patient safety and well-being. We address product safety issues with the highest priority and urgency. Our decision to implement this voluntary recall was necessary to ensure maximum patient safety. As our investigation continues, we remain committed to timely communication with physicians and regulatory authorities.”

In addition, as part of the voluntary recall of unused products, Medtronic sent written letters to physicians, recommending that they retrospectively review available imaging for all patients treated with the Valiant Navion Thoracic Stent Graft System, with particular attention to stent fractures and Type IIIb endoleaks. Medtronic urges physicians to adhere to best clinical practices and conduct follow-up evaluations at least annually, in accordance with the imaging recommendations outlined in the Instructions for Use (IFU) for the Valiant Navion Thoracic Stent Graft System.

As always, physicians are required to notify Medtronic of any adverse events or product safety issues associated with the use of any Medtronic product, and such incidents should also be reported to the U.S. FDA’s MedWatch Adverse Event Reporting Program. Outside the United States, adverse events or product safety issues related to the use of Medtronic products should be reported to the relevant regulatory authorities.

Reference Source:

1.Medtronic recalls aortic graft implant after stent fractures, patient death

2.Medtronic Announces Voluntary Recall of Unused Valiant Navion™ Thoracic Stent Graft System