Trifecta GT Heart Valve Lawsuit Alleges Premature Failure Led to Patient’s Death

Part of the Trifecta GT heart valve was found to have torn loose, which the lawsuit alleges is an indication of poor manufacturing.

A Nebraska widow has filed a Trifecta GT heart valve failure lawsuit, blaming an alleged manufacturing defect for her husband’s death.

The complaint (PDF) was brought by Amy Nachman in Nebraska state court on August 31, following the death of her husband, Alan Potash. The case was subsequently removed to the U.S. District Court for the District of Nebraska on October 1 by the defendants, which include St. Jude Medical, Cardiology Division Inc., the original developer of the Trifecta heart valve, and Abbott Laboratories Inc., which acquired St. Jude in 2017.

Nachman alleges that the Trifecta GT heart valve implanted in her late husband was manufactured outside required specifications and that, when the device was surgically removed, doctors discovered structural damage that she claims contributed directly to his death.

Trifecta Heart Valve Complications

The Trifecta heart valve is implanted in patients suffering from damaged or diseased aortic valves, which are a key part of the circulatory system, delivering oxygenated blood to the rest of the body. The original model was approved by the U.S. Food and Drug Administration (FDA) in 2011. The Trifecta GT model followed in 2016.

In July 2023, Abbott Laboratories pulled all Trifecta heart valves from the market due to concerns of premature structural valve deterioration (SVD). The move followed FDA warnings that some Trifecta prosthetics were experiencing early valve failure at unacceptably high rates. The FDA received approximately 3,000 adverse event reports involving Trifecta devices between 2011 and 2023, linking the implants to nearly 200 deaths.

This has led to several Trifecta heart valve lawsuits being filed in recent months, each indicating that design or manufacturing of the devices was defective. Individuals claim the valves suffered early SVD, leading to serious and life-threatening health complications for themselves, or the deaths of loved ones.

Trifecta Heart Valve Failure Allegations

According to the complaint, Potash received a 21-mm Trifecta GT with Glide Technology during an implantation procedure in February 2018. However, Nachman alleges that the device he was implanted with had a structural flaw, which means it did not meet the device specifications set when the Trifecta GT was first approved.

Nachman alleges that the Trifecta heart valve failed, causing severe aortic regurgitation that required replacement surgery in September 2024. During the procedure, surgeons discovered that one of the valve’s leaflets had completely torn away.

The leaflet that doctors found torn away from Potash’s Trifecta GT heart valve was supposed to be treated and properly sewn onto the valve to provide support. Nachman argues that had the device been made to the proper specifications, it would not have failed.

Just days after the replacement procedure, Potash died from health complications, according to the lawsuit. Nachman claims that the manufacturers knew, or should have known, about this problem for years and St. Jude should have never placed the devices on the market.

“Peer-reviewed clinical literature confirmed that Defendant Abbott and Defendant St. Jude’s Trifecta Valve exhibits reduced durability and heightened susceptibility to premature structural valve deterioration compared to other surgical bioprostheses. However, these findings were not reported by Defendant Abbott and/or Defendant St. Jude as required by its PMA (premarket approval).”

– Amy Nachman v. Abbott Laboratories Inc. et al.

The filing raises allegations of manufacturing defect, negligent manufacture, negligence, failure to warn, breach of express and/or implied warranty, wrongful death and survivor action. It seeks compensatory damages for Potash’s pain, suffering, disability, medical expenses, lost earnings and other damages linked to the Trifecta GT heart valve failure.

Trifecta Heart Valve Lawsuits

While the implants are no longer sold, there are still individuals who are implanted with the devices that may experience valve failure. Those individuals may qualify for a Trifecta Heart Valve lawsuit if they suffered the following complications:

Trifecta heart valve attorneys are currently reviewing potential claims. Free consultations are available to individuals seeking to determine whether they may be eligible for compensation. These cases will be handled on a contingency-fee basis, meaning there are no upfront legal fees or expenses, and attorneys only receive a fee if they obtain a settlement or verdict.

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