The original recall notice included the 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 instructions for use (IFU). This guidance was based on the available information at the time as well as advice from an independent panel, Medtronic notes.
The company is now recommending that physicians proactively contact patients implanted with the Valiant Navion and perform computed tomography (CT) imaging with contrast every six months, or as frequently as deemed appropriate by the physician’s medical judgement. It specifies that, while CT imaging with contrast is necessary for a full evaluation of the stent graft, non-CT is recommended for patients with contraindications to contrast. Moving forward, the company is requesting that physicians provide all prospective patients follow-up images for independent core lab review.
Medtronic has also provided information for patients to help them understand the updated recommendations, with direction to consult their physician with concerns following implant of the Valiant Navion and to discuss the best approach for their ongoing care.
The updated information, which was originally sent to physicians on 21 May, can be found here.