Abbott Trifecta Valves

Last July, Abbot, the manufacturer of Trifecta Valves, announced that it would stop selling Trifecta Valves. Among the valves that are it no longer sells are the Trifecta Valve and the Trifecta Valve with Glide Technology, on which leaflets are mounted to the outside of valve frames. This recall followed on the heels of Abbot’s February 2023 letter warning health care providers that there was a potential risk of early structural valve deterioration. The FDA made several recommendations in connection with the valves and is continuing to work with Abbott to figure out the extent of the risks of the structural deterioration. If you were harmed by an Abbott Trifecta Valve, you should contact the seasoned Chicago-based lawyers of Moll Law Group. We represent plaintiffs around the country—billions have been recovered in lawsuits with which we’ve been involved.

Trifecta and Trifecta Valve with Glide Technology (Trifecta Valve GT) valves are meant to treat those who have diseased aortic heart valves. They are also used to replace prosthetic aortic heart valves if those malfunction or get damaged. In 2011, the first generation Trifecta valve was first approved by the FDA, and in 2016, the Trifecta Valve GT was approved. Since then, literature has been accumulated that compares these valves to other bovine pericardial valves across time after they’ve been implanted. Other valves, in those studies, required less reintervention than the Trifecta valves. Additionally medical device reports describe the deterioration occurs three to four years after the Trifecta valve is implanted in the context of surgical valve replacement/explant and transcatheter valve-in-valve intervention. If we take your case, we would need to work closely with experts to determine the relationship between the deteriorated valve and any harm you suffered, in addition to figuring out what damages are appropriate.

Among other things, experts will evaluate evidence about when the company and providers knew that the valve has the potential for structural deterioration. The U.S. Food and Drug Administration (FDA) told health care providers about the potential risk of early structural valve deterioration (SVD) after studies suggested that there was a higher cumulative incidence of early deterioration for the Trifecta valves when studied alongside other surgical bioprosthetic valves that are available on the market. If you believe you were injured by a defective valve, you should report the adverse event to the FDA so that it can continue to study the risks associated with the valves. Health care providers now are expected to be aware of the potential risk of early valve deterioration with Trifecta valves.

The FDA recommends that health care providers talk about risks and advantages of all available treatment options related to aortic valves with patients and caregivers when making decisions about care, before surgery happens. Providers are also supposed to follow instructions for use in implanting the valve and also keep track of the wellbeing of patients that have been implanted with Trifecta valves. There may be signs and symptoms of deterioration and it’s important for providers to check for them. As a patient, you are advised to get medical care if you develop fatigue, shortness of breath, or other symptoms, and you should visit the doctor for follow-ups every year for the rest of your life. A follow-up visit should include a transthoracic echocardiogram (TTE) assessment of the valve, starting a year after you are implanted.

The FDA is continuing to work with Abbott to evaluate the safety of the Trifecta Valves, which are still implanted in many patients and to put together further patient management strategies. Your report of an adverse event can assist with the FDA’s monitoring. While Abbott has called for defective valves to be sent back, those used valves may prove important as evidence in a lawsuit for damages, and may be needed by litigation experts for evaluation, so it is important to retain them.

If you were already injured or a loved one died as a result of an Abbott Trifecta Valve, these current recommendations won’t do you much good. You should be aware that you may be able to recover damages from the manufacturer, and in some cases, you may also recover damages from a physician who did not pay attention to the warnings or the recall last year. It is crucial to seek counsel from seasoned attorneys who can look into your case and evaluate whether you have a claim.

Both product liability and medical malpractice theories may apply in lawsuits for compensation. Our lawyers represent plaintiffs who have been harmed around the country. If you were harmed by an Abbott Trifecta Valve, please contact our experienced Chicago-based trial attorneys about your legal options, either by completing our online form or by calling us at 312.462.1700.