Medtronic is voluntarily recalling unused Valiant Navion thoracic stent grafts worldwide after reports of stent fractures surfaced from the Valiant Evo Global clinical trial.
Two patients have confirmed type IIIb endoleaks and one patient has died, according to the company.
Following these three reports, an independent imaging laboratory reviewed all images from the trial and reported that 7 out of 87 patients (8%) had stent ring enlargement beyond the design specification.
"Those observations require further assessment to determine potential clinical importance," the company said in a press release. "Medtronic is currently conducting a comprehensive technical root cause investigation, including further review of follow-up clinical trial imaging and commercial complaints and imaging."
As part of the global recall, Medtronic has asked physicians to immediately stop using the devices and return unused product to the company.
"Medtronic advises 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 recall noted.
The company is also asking physicians to evaluate patients with at least annual follow-up according to the imaging recommendations in the device instructions for use, and to report any adverse events or product safety issues.
The Valiant Navion thoracic stent graft system was approved in 2018 in the US for minimally invasive repair of all lesions of the thoracic aorta.
Data from the simultaneously run Valiant Evo US and Valiant Evo International trials were combined to create a global cohort of 100 patients, of which 87 patients were implanted with the device and evaluable for the primary safety and efficacy endpoint at 30 days. Neither trial is currently recruiting.
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Cite this: Medtronic Recalls Valiant Navion ThoracicStent Grafts - Medscape - Feb 17, 2021.