FDA has categorized Medtronic's recall of the Valiant Navion Thoracic Stent Graft System as a Class I event.
Medtronic initiated a recall of the cardiovascular disease devices in February after a patient died in a clinical trial. The death and other cases pointed to a risk of what are known as Type IIIb endoleaks.
The potential for these to lead to aneurysm rupture led FDA to put the recall of 14,237 devices from the U.S. in its highest risk category.
The recall deprives Medtronic of a source of sales growth. Then-Medtronic CEO Omar Ishrak talked up the potential for the device to capture share and drive incremental growth shortly after it won approval, and discussed its double-digit contribution to growth of the aortic, peripheral and venous business on subsequent quarterly results conference calls.
Medtronic won FDA approval for the Valiant Navion system in the minimally invasive repair of lesions of the descending thoracic aorta in 2018. Approval was based on data from a trial that enrolled 100 people who were candidates for endovascular repair between April 2016 and October 2017. After 30 days, one patient had a Type Ia endoleak and another patient had a Type II endoleak.
Type I endoleaks occur when there is a gap between the graft and the vessel wall. Type II endoleaks, the most common type, happen when pressure changes cause blood to leak back into the aneurysm sac. Type III endoleaks reflect a fault or misalignment of endograft components. As Type III endoleaks can lead to aneurysm rupture, they require urgent attention.
Medtronic has identified four cases of Type III endoleaks in the clinical trial, as well as four cases of stent fracture and seven cases of stent ring enlargement beyond the design specification. Some patients were affected by more than one of the problems. One patient died after reintervention.
As of the February recall, Medtronic had received two complaints of Type IIIb endoleak, one of which also reported a stent fracture, across the more than 14,000 patients who had received the device globally outside of clinical trials. Medtronic received FDA approval and a CE mark late in 2018, around one year after it completed enrollment in the clinical trial.
Medtronic has advised physicians to immediately stop using the stent graft system and return the devices. For existing patients, Medtronic is recommending physicians review all images to check for signs of faults and perform at least annual follow-up.