Updated patient management recommendation for patients implanted with recalled Medtronic Valiant Navion™ Thoracic Stent Graft System

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of important updates to the patient management recommendations related to the recall of the Medtronic Valiant Navion^™ Thoracic Stent Graft System issued on 19 February 2021, due to cases of stent fractures, Type IIIb endoleaks and stent ring enlargement. Healthcare professionals are now advised to proactively contact patients implanted with the Valiant Navion Thoracic Stent Graft^™ and perform computerized tomography (CT) imaging with contrast every six months, or as frequently as deemed appropriate by the physician's medical judgement. CT imaging with contrast is necessary for a full evaluation of the stent graft; a non-contrast CT is recommended for patients with contraindications to contrast. Medtronic is also requesting physicians provide all prospective patient follow-up images for independent core lab review. Healthcare professionals are reminded to retrospectively review all available images of Valiant Navion patients to identify signs of Type IIIb endoleak, stent fracture, and/or stent ring enlargement and develop an appropriate treatment and/or monitoring plan, or treat in accordance with the standard of care practices or the medical society guidelines. Please refer to the letter for details. Published: 28 May 2021

Dear Healthcare Professional Letters