SAPIEN 3 Transcatheter Heart Valve System Lawsuit Lawyer

Our law firm is currently handling lawsuits on behalf of individuals who have suffered injury or death after using the Edwards SAPIEN 3 Transcatheter aortic valve replacement (TAVR). Lawsuits against the manufacturers of TAVR claim that the devices can malfunction and have the potential to cause vascular injury and bleeding or require surgery.

What Do We Know about SAPIEN 3 Transcatheter Aortic Valve Replacement Lawsuits?

TAVR devices are indicated for patients with severe symptomatic aortic stenosis (a narrowing of the aortic valve which limits blood flow to the main artery) and are at high risk of surgery. TAVR was designed to streamline the procedure by replacing the diseased valve without open heart surgery. The use of TAVR devices in lieu of open-heart surgery has become increasingly popular despite questions about its long-term risks.

The company reported that complications occurred when physicians attempted to retrieve the delivery device and remove it from the patient’s body due to the risk of rupturing balloons. Edwards released an Urgent Field Safety Notice in July 2019 to improve instructions on device retrieval. In addition, the company noted it would warn practitioners that failure to use slow, controlled movements to inflate the balloon may lead to balloon rupture, difficulty removing the system and surgical intervention. At that time, 1,585 devices were recalled following the company Notice to the public.

SAPIEN 3 Transcatheter Aortic Valve Replacement Injuries

Balloon rupture in TAVR devices may result in vascular injury, embolism, bleeding, stroke, difficulty retrieving the system, surgical intervention, and death. The manufacturer indicated that there was a complaint rate of 1% with half of those case having clinical significance.

How Our Law Firm Can Help You

The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 274-0139 or submit an inquiry on this page.

SAPIEN 3 Transcatheter Aortic Valve Replacement and FDA Alerts

The Food and Drug Administration (FDA) issued a Class I recall of TAVR devices in August 2019 after reports of balloons bursting during implantation. A Class I recall is the most serious recall by the FDA. At the time of the FDA’s recall, the agency was notified of 17 reports of injuries and at least one report of death.