Sapien 3 TAVR Lawsuit Claims Valve Caused Iliac Artery Perforation, Wrongful Death

Lawsuit alleges defects involving an Edwards Lifesciences Sapien 3 Ultra heart valve caused catastrophic vascular injuries during a TAVR procedure, resulting in a woman’s death.

A Louisiana man has filed a Sapien 3 TAVR lawsuit alleging his mother died from severe injuries after an Edwards Lifesciences heart valve and related delivery devices perforated her iliac artery and abdominal aorta during an implantation procedure.

The complaint (PDF) was brought by Timothy Paul Broussard on behalf of himself and his deceased mother, Brenda Carol Goudry, in the U.S. District Court for the Western District of Louisiana on July 13, naming Edwards Lifesciences LLC as the defendant.

Broussard claims the Edwards Sapien 3 Ultra transcatheter heart valve and related delivery systems were defectively designed and manufactured, causing catastrophic injuries during a transcatheter aortic valve replacement (TAVR) procedure.

Sapien 3 TAVR Vascular Injury Risks

The Sapien 3 Ultra is a balloon-expandable replacement heart valve manufactured by Edwards Lifesciences for use during TAVR procedures.

TAVR is a less-invasive alternative to open-heart surgery for patients with severe aortic stenosis, a condition that occurs when the aortic valve narrows and restricts blood flow from the heart.

During the procedure, doctors use a catheter to guide the replacement valve through the patient’s blood vessels and position it inside the damaged aortic valve.

While TAVR can reduce the need for open-heart surgery, studies have identified potential risks involving stroke, bleeding and damage to the blood vessels. In January, Japanese researchers found TAVR procedures may damage healthy red blood cells, potentially contributing to hemolytic anemia and other complications.

A separate study published in 2024 found balloon-expandable replacement valves used during TAVR procedures were associated with an increased risk of valve dysfunction and death. Researchers determined the devices were four times more likely to fail or develop blood leaks.

Sapien 3 TAVR Wrongful Death Allegations

According to the lawsuit, Goudry underwent a TAVR procedure in October 2024 to treat severe aortic stenosis. Doctors used an Edwards Sapien 3 Ultra valve, Commander delivery system and related devices manufactured by Edwards Lifesciences.

However, the complaint alleges defects involving the valve and delivery systems allegedly caused or contributed to severe damage to Goudry’s blood vessels. It further alleges that the devices perforated the iliac artery, which carries blood through the pelvis and into the legs, as well as the abdominal aorta, the body’s largest artery.

The lawsuit states that despite emergency medical efforts, Goudry died from her injuries.

Broussard claims Edwards Lifesciences knew or should have known its TAVR products could cause serious vascular injuries, including perforations, internal bleeding and death.

The lawsuit alleges the company failed to adequately design, manufacture and test the devices or provide sufficient warnings about the potential risks. It also argues that Edwards Lifesciences failed to properly investigate reports of similar problems and continued marketing the products as safe and effective for TAVR procedures.

Broussard argues that his mother experienced severe pain, suffering and emotional distress before her death as a result of the injuries caused during the TAVR procedure.

“Ms. Guidry was pronounced dead at 11:49 AM on January 2, 2024. Her death certificate lists exsanguination (approximately two hours duration) due to vascular trauma during TAVR as the cause of death.”

— Timothy Paul Broussard v. Edwards Lifesciences LLC

The lawsuit raises allegations of construction or composition defect, design defect, inadequate warning, breach of express warranty, breach of implied warranties of merchantability and fitness, redhibition and breach of warranty of fitness for ordinary use. It is seeking damages for injuries and losses allegedly caused by the defective heart valve and delivery devices.

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