Medical device manufacturer, Medtronic, has issued a global voluntary recall concerning its Valiant Navion Thoracic Stent Graft System.
The recall is being initiated in response to information identified in the manufacturer's Valiant Evo Global Clinical Program, which studied the performance of the Valiant Navion Thoracic Stent Graft System. According to the manufacturer, of the 100 subjects enrolled in the abovementioned program there were three subjects with stent fractures, of which two have confirmed Type IIIb endoleaks - Type IIIb endoleaks, if untreated, can potentially lead to aneurysm rupture. The first patient event was reported on 21 December 2020 and the second patient event was reported on 27 January 2021. The first patient died following reintervention, and the death was determined to be aneurysm-related. As of 13 February 2021, a review of the available images from the program has identified seven patients with stent ring enlargement beyond the design specification and one stent fracture, which requires further clinical assessment.
The manufacturer has also reported to have received two complaints for patients treated outside the original clinical trial with the affected device. These complaints were reported out of approximately 14,000 patients with the implant. The manufacturer is currently conducting a comprehensive technical root cause investigation, including full review of follow-up clinical trial imaging, as well as commercial complaint and imaging data analysis. An Independent Physician Quality Panel composed of thoracic aortic specialists has been engaged to advise on appropriate patient management.
The manufacturer is advising users to immediately cease use of the Valiant Navion Thoracic Stent Graft System and return any unused product.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 February 2021