Medtronic is making updated patient management recommendations related to its voluntary recall of the Valiant Navion™ Thoracic Stent Graft on February 17th, which included the patient recommendation for physicians to follow best clinical practice and make best efforts to evaluate patients with at least annual follow-up according to the recommendations in the IFU. This recommendation was based on the available information at the time as well as advice from the independent physician quality panel.
The company has provided physicians with an update on Valiant Navion observations, and is recommending physicians proactively contact patients implanted with the Valiant Navion Thoracic Stent Graft and perform computerized tomography (CT) imaging with contrast every six (6) 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; however, a non-contrast CT is recommended for patients with contraindications to contrast. Moving forward, Medtronic is requesting physicians provide all prospective patient follow-up images for independent core lab review.
Medtronic will provide ongoing support for these recommendations, including a mechanism for physicians to upload prospective images and a physician and patient assistance program – all of which will be the subject of further communication.
Please see link to access the information sent to physicians on May 21, 2021, as well as a patient website to help patients understand the updated patient management recommendations with direction to consult their physician with concerns following implant of the Valiant Navion Thoracic Stent Graft System and to discuss the best approach for their ongoing care.