Recall of Medtronic Valiant Navion™ Thoracic Stent Graft System due to cases of stent fractures, Type IIIb endoleaks and stent ring enlargement

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of a recall of the Medtronic Valiant Navion^™ Thoracic Stent Graft System in response to cases of stent fractures, Type IIIb endoleaks and stent ring enlargement identified in a clinical programme. Type IIIb endoleaks, if untreated, can potentially lead to aneurysm rupture. Healthcare professionals are advised to immediately cease use of the Valiant Navion^™ Thoracic Stent Graft System and return any unused product to Medtronic. Healthcare professionals are recommended to follow best clinical practices and to make best efforts to evaluate affected patients with at least annual follow-up according to the imaging recommendations in the Instructions For Use. Healthcare professionals are also advised to retrospectively review all available images of patients treated with Valiant Navion^™ Thoracic Stent Graft with specific attention to stent fractures and Type IIIb endoleaks and to contact Medtronic if any imaging findings are identified. Please refer to the letter for details. Published: 19 Feb 2021

Dear Healthcare Professional Letters