Time May Be Running Out: Patients Implanted with Abbott Trifecta Heart Valves Urged to Act Now

FDA Cautions of Early Valve Failure, and Legal Deadlines Could Be Near

When Abbott announced in July 2023 that it would stop selling and distributing its Trifecta and Trifecta GT heart valves in the U.S., the decision marked a major moment for patient safety. The FDA has since warned that these devices may be linked to early structural valve deterioration (SVD) — meaning some valves are failing within just three to five years after implantation.

For patients and families affected, this isn’t just a medical crisis — it may also be a legal one, and time is running out to take action.

What the FDA Has Said About the Abbott Trifecta Valves

According to the FDA’s letter to health care providers, reports and medical literature suggest the Trifecta valves may fail much sooner than comparable devices. These failures have been linked to serious complications such as:

• Valve leakage or rupture
• Heart failure
• Emergency reoperation
• Death

The issue involves Abbott’s design choice — the Trifecta’s leaflets are externally mounted on the valve frame, a feature that may make the valve more prone to early deterioration. Patients have reported shortness of breath, fatigue, and cardiac distress within just a few years of receiving the implant.

The FDA continues to evaluate the risks and has recommended lifelong monitoring, including yearly echocardiograms, for patients who have received these valves.

Why the Statute of Limitations Matters Now

While Abbott halted U.S. distribution in 2023, many patients received Trifecta valves between 2016 and 2021, when the devices were most widely used. That means the three-year statute of limitations for product liability lawsuits — in states such as Pennsylvania, Massachusetts, and North Carolina — could expire as early as next year for some patients.

Even if your symptoms appeared recently, or if your doctor only recently linked them to valve failure, it’s crucial to speak with an experienced medical device attorney now. Missing this window could bar you from recovering compensation for:

• Medical costs
• Revision surgeries or valve replacement
• Lost wages or earning capacity
• Pain, suffering, and loss of quality of life

Ketterer, Browne & Davani (KBD) is actively monitoring Trifecta-related injury reports and helping patients and families understand their rights before legal deadlines pass.

How Structural Valve Deterioration Happens

Structural valve deterioration (SVD) occurs when the implanted heart valve weakens, stiffens, or ruptures. In the Trifecta’s case, published studies have shown a higher rate of early SVD compared to other bovine pericardial valves.

Patients who have undergone open-heart surgery to receive one of these valves often expect them to last 10 to 15 years. Unfortunately, some Trifecta valves have failed in less than five years, leading to emergency replacements and additional surgeries — procedures that are risky, costly, and emotionally devastating.

The FDA has received multiple reports of:

• Explantation and replacement surgeries
• Valve-in-valve interventions
• Deaths linked to early failure

If you or a loved one experienced any of these complications, you may have a valid claim.

KBD Attorneys Are Investigating Trifecta Valve Cases Nationwide

At Ketterer, Browne & Davani, our firm has a proven record of holding medical device manufacturers accountable when their products fail to protect patients. We’re currently reviewing claims involving:

• Abbott’s Trifecta and Trifecta GT heart valves
• Medtronic and Edwards Lifesciences valve systems
• Other defective implantable devices that have caused catastrophic injury or death

Our legal team can help you:

1. Determine if your device was a Trifecta valve
2. Review your surgical and cardiac records
3. Connect with medical experts to confirm evidence of early deterioration
4. File your claim before the statute of limitations expires

We understand how confusing medical device warnings can be — especially when years pass before problems are discovered. That’s why KBD is committed to spreading awareness now, before it’s too late for affected families to seek justice.

Why This Awareness Still Matters

Even though the FDA’s warnings first surfaced in early 2023, the legal and medical consequences are still unfolding. The agency continues to monitor reports of early failure, but no recall has been issued, leaving many patients unaware they may be at risk.

At KBD, we’re using our platform to ensure this information reaches those who need it most. We’ve warned about defective implants, catheters, and surgical devices before — and the pattern is clear: companies often act too late, and patients suffer the consequences.

If you or someone you love received a Trifecta or Trifecta GT heart valve, contact our firm today for a free case evaluation. Time may be limited — but help is available now.