SAPIEN 3 Transcatheter Heart Valve System Lawsuit Lawyer

.Over 500,000 individuals undergo open heart surgery every year. Medical professionals usually reserve this intensive procedure to correct complications to the aorta or heart itself. After surgery, patients may require at least a week in the hospital and should expect a lengthy recovery time. To avoid complications or reduce the number of open heart surgeries, surgeons have used the Edwards SAPIEN 3 Transcatheter Heart Valve System. This device asses the need for open heart surgery, but doctors have reported several adverse health events to the FDA. Did you or a loved one suffer health complications or death due to Edwards SAPIEN 3 THV? Reach out to us at The Lake Law Firm to learn more about how a SAPIEN 3 Transcatheter Heart Valve System lawsuit can benefit you.

Our law firm is currently handling lawsuits on behalf of individuals who suffered injury or death after using the Edwards SAPIEN 3 Transcatheter Heart Valve System. Lawsuits against the manufacturers of Edwards SAPIEN 3 THV claim that the devices can malfunction and cause vascular injury and bleeding or require surgery.

What is the Edwards SAPIEN 3 Transcatheter Heart Valve System?

The Ewards SAPIEN THV is a catheter-based artificial heart valve that consists of cow tissue attached to a frame with an expandable balloon. The FDA approved the device in 2020 to treat patients with severe aortic stenosis. This condition occurs when the aortic valve narrows and limits blood flow to the body’s main artery, the aorta. Additionally, the agency granted approval for use in patients with pulmonary regurgitation and pulmonary stenosis. The Edwards SAPIEN 3 THV serves as an artificial heart valve that surgeons can implant without the need for open heart surgery.

Surgeons compress and attach the device to a balloon catheter. Next, the surgeons snake the equipped balloon catheter through a large vein in the leg until it reaches the pulmonary valve. A balloon expands the artificial valve which latches onto the faulty valve. The Edwards SAPIEN 3 THV will function as the new valve and force blood flow in the proper direction.

Complications with the Heart Valve Device

Edwards SAPIEN 3 THV devices in lieu of open heart surgery have become increasingly popular despite questions about its long-term risks. The company reported that complications arise 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. Furthermore, 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.

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. Devices in this category present a serious risk of injury or death in users. At the time of the FDA’s recall, the agency received 17 reports of injuries and at least one report of death. The recall applied to 1,585 devices.

SAPIEN 3 THV Injuries

If the balloon bursts, surgeons will have a very difficult time attempting to safely retrieve the device. Removal of the ruptured balloon is a very delicate maneuver. Other arteries or valves may tear or rupture in the process. Balloon rupture in TAVR devices may result in:

  • Vascular injury
  • Embolism
  • Bleeding
  • Stroke
  • Surgical intervention
  • Death

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

Edwards Lifesciences designed the SAPIEN 3 Transcatheter Heart Valve to streamline complex heart procedures by replacing the diseased valve without open heart surgery. However, medical professionals have complained of catastrophic hazards associated with the device’s balloon feature. The balloon may rupture and jeopardize the health and life of patients. Also, researchers remain unsure as to the long-term durability of artificial heart valves like the Edwards SAPIEN 3 THV.

Liability Law and SAPIEN 3 Transcatheter Heart Valve System

  • Patients may have a product liability claim against Edwards Lifesciences for the defective device that presented unreasonable dangers for patients.
  • Lawsuits may hold Edwards Lifesciences responsible for failing to adequately warn doctors and patients of the risks of its SAPIEN 3 THV system.

Can I Recover Compensation in a SAPIEN 3 Transcatheter Heart Valve System Lawsuit?

If an Edwards SAPIEN 3 THV device injured you or a loved one, you may recover compensation for any or all of the following:

  • Past and future medical expenses;
  • Past and future pain and suffering;
  • Loss of wages; and
  • Other economic losses related to your injury.

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.