Abbott Warns of Potential Deterioration in Trifecta Heart Valves

Abbott has issued an advisory to customers warning of potential early structural valve deterioration (SVD) of its Trifecta Valve and Trifecta Valve with Glide Technology (GT) bovine heart valves, occurring five years or less after being implanted.

The valves are intended to treat diseased, damaged, or malfunctioning native or replacement aortic heart valves. The Trifecta valves use a covered titanium stent with externally mounted leaflets that are designed to maximize the heart valve opening.

In addition to the warning by the company, the FDA posted information on its website, advising that the Trifecta valves have a higher early incidence of SVD compared to other commercially bovine pericardial valves as well as an increased need for reintervention.

The FDA said it had received medical device reports of early SVD with the Trifecta valves, which show a peak time to SVD of three to four years after implant. Adverse reported outcomes include surgical valve replacement, transcatheter valve-in-valve intervention, and in some cases death.