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Trifecta Heart Valve Lawsuit Investigation Overview

Abbott Laboratories withdrew its Trifecta and Trifecta GT heart valves from the U.S. market in 2023, after federal regulators and independent researchers linked the devices to an unusually high rate of early structural valve deterioration. Since then, evidence has shown that the Trifecta valves can fail years earlier than expected, putting patients at risk of severe and sometimes fatal complications.

Thousands of reports have been submitted to the FDA involving premature valve deterioration, leaflet tears, and calcification, which have caused patients to experience heart failure, stroke, blood clots, and death. These failures may be the result of design flaws, which make the valve leaflets more likely to weaken or tear under normal pressure inside the heart.

Although the devices are no longer being sold, concerns remain for patients who still have Trifecta valves implanted. Lawyers are evaluating the potential for lawsuits against Abbott and its predecessor, St. Jude Medical, involving allegations that the manufacturers knew the valves were prone to early deterioration, yet failed to warn doctors or patients before the market withdrawal.

Potential cases are being evaluated for individuals who received an implantable heart valve and suffered any of the following complications:

• Heart Failure
• Open Heart Surgery
• Valve Stenosis
• Valve Regurgitation
• Valve Replacement Surgery
• Stroke
• Blood Clots
• Wrongful Death

What is the Trifecta Heart Valve?

The Abbott Trifecta and Trifecta GT valves are surgical bioprosthetic heart valves designed to replace a patient’s natural aortic valve when it becomes diseased or damaged. These devices are made from bovine pericardial tissue, which is the protective sac surrounding a cow’s heart, and mounted on a stent that gives the valve its shape and keeps it securely in place once implanted.

The valve is named “Trifecta” because it is built with three flexible leaflets, replicating the structure of a healthy human aortic valve. These leaflets open and close with each heartbeat, allowing oxygen-rich blood to flow from the left ventricle into the aorta, then sealing tightly to prevent blood from flowing back into the heart.

Unlike mechanical valves, the Trifecta models were marketed as providing a more natural blood flow and eliminating the need for long-term blood-thinning medication. They were intended to help patients suffering from aortic valve disorders, particularly aortic stenosis and aortic regurgitation, which can severely limit the heart’s ability to circulate blood effectively.

Aortic Stenosis

Aortic stenosis occurs when the aortic valve becomes narrowed or stiff, restricting blood flow from the left ventricle into the aorta. The condition forces the heart to work harder to pump blood through the narrowed opening, which can eventually lead to thickening of the heart muscle and decreased cardiac efficiency. Over time, this strain can cause fatigue, fainting, and symptoms of heart failure if left untreated.

Common symptoms of aortic stenosis include:

• Shortness of breath during activity
• Chest pain or tightness (angina)
• Fatigue or weakness
• Dizziness or fainting spells
• Irregular heartbeat or heart murmur

Aortic Regurgitation

Aortic regurgitation (or aortic insufficiency) occurs when the aortic valve does not close tightly, allowing blood to leak back into the left ventricle after each heartbeat. This backward flow increases the volume of blood the heart must pump, gradually enlarging and weakening the ventricle. In severe cases, it can lead to heart failure or the need for surgical valve replacement.

Common symptoms of aortic regurgitation include:

• Chest discomfort or pounding heartbeat
• Shortness of breath (especially when lying flat)
• Fatigue or lightheadedness
• Heart palpitations
• Swelling in ankles or feet

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What Is The Problem With the Trifecta Valve?

The Trifecta heart valves have been linked to early structural valve deterioration (SVD) and leaflet tears, which may prevent proper blood flow and lead to severe complications.

First-generation valves were quietly phased out after early failures involving tissue degeneration and cusp tears. Abbott’s later Trifecta GT model, approved in 2016, included a Linx anticalcification coating meant to improve durability, but it was also reported to fail within five years of implantation.

Common Trifecta Valve Malfunctions

• Device deterioration and leaflet tears: As the valve’s leaflets weaken or tear, they can no longer open and close properly. This disrupts normal blood flow, creating turbulence inside the heart and placing extra strain on the left ventricle.

• Valve calcification and stiffening: Calcium deposits can form on the biological tissue of the valve, making the leaflets rigid and less flexible. When the valve cannot open fully, pressure builds up in the heart and circulation becomes less efficient.

• Valve narrowing (stenosis): Stenosis occurs when the valve opening becomes too small for blood to pass through freely. In Trifecta valves, this often develops after calcification or warping of the leaflets, forcing the heart to pump harder and reducing oxygen delivery to the body.

• Blood leaks (regurgitation): If the valve cannot close completely, blood may leak backward into the heart. This condition, known as regurgitation, increases the heart’s workload and can lead to fatigue and swelling as fluid accumulates.

• Complete valve failure: When multiple structural issues occur together, such as tears, calcification, and restricted movement, the valve can stop functioning entirely. This typically requires emergency open-heart surgery to replace the failed device.

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Trifecta Valve Failure Injuries and Deaths

Although Abbott marketed the Trifecta valves as safe, long-lasting alternatives to mechanical heart valves, thousands of patients have reported serious health complications after implantation.

Between 2011 and when Abbott finally recalled Trifecta heart valves from the market, nearly 3,000 adverse event reports were submitted to the FDA, including more than 2,100 injuries and 191 deaths associated with the Trifecta and Trifecta GT models.

When these valves deteriorate prematurely, the body cannot maintain normal blood circulation. This can cause rapid declines in heart function, sudden hospitalizations, and the need for emergency surgery. In some cases, patients have died before a replacement procedure could be performed.

Trifecta Valve Failure Side Effects

• Heart failure: When the valve can no longer regulate blood flow, the heart becomes overworked and unable to pump efficiently, leading to shortness of breath, swelling, and fluid buildup in the lungs.
• Blood clots and stroke: Irregular blood flow around damaged valve tissue can cause clot formation, which may travel to the brain and result in a stroke or transient ischemic attack.
• Infection (endocarditis): Bacteria can collect on torn or degraded valve surfaces, leading to infection of the heart’s inner lining that often requires prolonged hospitalization and IV antibiotics.
• Open-heart revision surgery: Many patients have required high-risk replacement procedures within just a few years of implantation, despite the valve being expected to last 15 to 20 years.
• Chest pain and fatigue: As the heart struggles to push blood through or around a failing valve, patients may experience persistent chest tightness, weakness, and reduced exercise tolerance.
• Dizziness or fainting: Decreased cardiac output and poor oxygen delivery can cause frequent lightheadedness or fainting episodes, particularly during activity.
• Death: In the most severe cases, valve failure or complications during emergency replacement surgery have resulted in fatal outcomes.

Abbott Trifecta Valve Recall and Warnings

The safety profile of the Trifecta Valve family has prompted regulatory action and public alerts after evidence emerged showing unusually high rates of early structural valve deterioration (SVD). Health-care providers and patients who received the device are being advised to monitor for symptoms and consider follow-up evaluations given the device’s shortened lifespan.

FDA Warning over Trifecta Valve Failure Rates

On February 27, 2023, the U.S. Food and Drug Administration (FDA) issued a letter to health-care providers stating that the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT) show a higher cumulative incidence of early SVD compared to other commercial bioprosthetic aortic valves.

The agency cited published literature and adverse-event reports indicating peak Trifecta Valve failure often occurs within three to four years after implantation, well below the expected 15 to 20 year lifespan of tissue valves. It recommended heightened monitoring, annual imaging, and prompt reporting of adverse

2023 Trifecta Heart Valve Recall

Amid the FDA warning and a growing number of injuries and fatalities being reported by Trifecta valve recipients, on July 31, 2023, Abbott announced it would stop selling and distributing the Trifecta and Trifecta GT valves in the United States and instructed the return of any unused inventory.

Although the device was not formally recalled under FDA recall classifications, this voluntary market withdrawal effectively removed it from U.S. availability due to safety concerns. The FDA continues to monitor outcomes in implanted patients and collaborates with Abbott in ongoing evaluation of the early-SVD risk.

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Abbott Heart Valve Replacement Failure Studies

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Trifecta Heart Valve Lawsuit Investigations

As reports of early valve deterioration continue to grow, patients across the United States are now seeking representation to file potential claims against Abbott Laboratories and its predecessor, St. Jude Medical, over the design, marketing, and safety of the Trifecta and Trifecta GT heart valves.

Investigations claim Abbott placed profits over patient safety by continuing to sell the valves for years after learning they were prone to premature structural failure, resulting in thousands of adverse events, emergency surgeries, and deaths.

• The Trifecta and Trifecta GT valves were defectively designed, using external leaflet placement that made them more susceptible to tearing and calcification.
• Abbott and St. Jude failed to adequately test the durability of the valve before seeking FDA approval.
• The company misrepresented the product’s lifespan, promoting it as lasting 15 to 20 years even as failures were being reported within five.
• Abbott failed to timely report adverse events and device malfunctions to the FDA as required under federal medical device reporting rules.
• The company continued marketing and distributing the devices long after receiving evidence of widespread structural deterioration.
• Safer, feasible alternative valve designs were available but not pursued.

Potential Compensation for Trifecta Valve Injuries

Individuals and families bringing Trifecta heart valve lawsuits may be eligible for financial compensation through settlements or court judgments.

The exact value of a case will depend on the extent of medical complications, the need for additional surgery, and the lasting effects on a patient’s health and livelihood.

Potential damages may include:

• Medical expenses for emergency treatment, revision surgery, and long-term cardiac care.
• Lost wages or diminished earning capacity due to recovery or disability.
• Pain and suffering caused by ongoing cardiac symptoms and surgical trauma.
• Loss of consortium for spouses or partners.
• Wrongful death damages for surviving family members of patients who died due to valve failure.

Abbott Trifecta Heart Valve Lawsuit Examples

Trifecta Heart Valve Lawsuit Filed in Kentucky

In October 2025, a lawsuit was filed in the U.S. District Court for the Eastern District of Kentucky by plaintiff Ronald Luckey, who alleges his Trifecta GT Tissue Heart Valve failed less than six years after implantation. The complaint, originally filed in Fayette County Circuit Court and later removed to federal court, accuses Abbott Laboratories of negligence and product defects that led to severe cardiac injury and additional open-heart surgery.

Mr. Luckey underwent surgery in October 2018 to receive the valve and required revision surgery in September 2024 after doctors found early structural valve deterioration. His lawsuit claims Abbott:

• Marketed the Trifecta valves as safe and long-lasting despite mounting evidence of early failures
• Failed to properly test and disclose durability concerns
• Violated FDA post-market reporting and quality-system regulations
• Continued selling the valves until their 2023 withdrawal despite known risks

The lawsuit seeks damages for medical expenses, lost income, permanent impairment, and pain and suffering, citing Abbott’s failure to protect patients from a foreseeable device defect.

Trifecta Valve Cases Investigated Nationwide

If you or a loved one were injured by a Trifecta valve failure, submit information about your potential claim for review by a product liability lawyer.

Trifecta heart valve lawyers provide free claim evaluations and consultations.