Medtronic Updates Patient Management Recommendations Related to Valiant Navion Thoracic Device Recall

May 24, 2021—Medtronic advised that the company has sent to physicians updated patient management recommendations related to its voluntary recall of the Valiant Navion thoracic stent graft.

The voluntary recall was announced in February 2021 and 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 device’s Instructions For Use. This recommendation was based on the available information at the time as well as advice from the independent physician quality panel, noted Medtronic.

On May 21, the company 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 CT imaging with contrast every 6 months, or as frequently as deemed appropriate by the physician’s medical judgement.

According to Medtronic’s update, CT imaging with contrast is necessary for a full evaluation of the stent graft. However, a noncontrast CT is recommended for patients with contraindications to contrast. Going forward, Medtronic is requesting physicians provide all prospective patient follow-up images for independent core lab review.

Medtronic stated that it 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 communications.

The information sent to physicians on May 21 is available on the company website here, which also includes access to a patient-oriented website to help patients understand the updated patient management recommendations with direction to consult their physician with concerns after implant of the Valiant Navion thoracic stent graft system and to discuss the best approach for their ongoing care.