The company is recalling the device based on the data from the Valiant Evo global clinical trial
Medtronic has voluntarily recalled unused Valiant Navion thoracic stent graft system. (Credit: Medtronic)
Medical technology company Medtronic has voluntarily recalled the unused Valiant Navion thoracic stent graft system, as part of its commitment to patient safety.
The company stated that it has informed physicians to immediately stop use of the device until further notice.
Medtronic is recalling the device based on the data from the Valiant Evo global clinical trial, which indicated that three patients in the study were noticed to have stent fractures. with two of them confirming type IIIb endoleaks.
The company stated one death was also reported in the three cases.
Based on the observations, an independent imaging laboratory evaluated all available images from patients recruited in the Valiant Evo trial.
Seven out of 87 patients have been noticed to have stent ring enlargement beyond the design specification, upon further analysis of the images.
Medtronic said that the observations need further evaluation to determine potential clinical significance.
At present, the company is carrying out a comprehensive technical root cause investigation, including further assessment of follow-up clinical trial imaging and commercial complaints and imaging.
Medtronic has approached the US Food and Drug Administration (FDA) along with other regulatory bodies across the world to share data linked to this issue.
Medtronic cardiac vascular group’s structural heart and aortic president and senior vice president Nina Goodheart said: “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.”
In July last year, the company started the real-world and post-market study to assess the safety and effectiveness of the Valiant Navion thoracic stent graft system.
The multi-centre DISSECT-N trial was expected to recruit up to 200 patients with an acute or chronic thoracic aortic dissection at around 45 sites in North America, Europe, and Asia Pacific.