Federal regulators warn that balloons used in Sapien 3 heart valve catheters may burst during implantation, resulting in the most serious category of medical device recall, indicating that use of the product may result in severe injury or death.
The FDA announced the Sapien 3 transcatheter heart valve recall on August 22, following reports of the balloon bursting during implantation procedures. To date, the FDA is aware of more than a dozen injuries and one death reported in relation with the recalled transcatheter heart valves.
The recall applies to the Edwards SAPIEN 3 Transcatheter Heart Valve System used in conjunction with the Edwards SAPIEN 3 Ultra delivery system. The transcatheter heart valve systems are used to replace a diseased aortic valve without open-heart surgery in patients diagnosed with severe, symptomatic, aortic valve stenosis; a narrowing of the heart’s aortic valve which restricts blood flow to the body’s main artery.
The FDA warns the catheter balloons may burst during procedures, which will make it extremely difficult for surgeons to retrieve the valve to the catheter, and remove it from the patient. Patients are likely to experience severe vascular injury, bleeding events, and serious life threatening injuries.
Since July 2019, a total of 17 injuries and at least one fatality have occurred due to bursting catheter balloons, the FDA reports.
The recall affects all lots of SAPIEN 3 Ultra Delivery Systems manufactured by Edwards Lifesciences of Irvine, California from January 23, 2018 to present. Approximately 1,585 recalled devices were distributed for sale throughout the United States to hospitals and surgical centers.
Edwards Lifesciences issued an Urgent Field Safety Notice on July 9, 2019, with instructions for physicians to follow when using the devices. All customers are being instructed to carefully follow the detailed instruction son the corrective notice, and to contact Edwards Lifesciences, LLC’s Associate Manager of Quality at 949-250-1572 for further information or questions.
A Class I recall is considered the most dangerous of recalls by the FDA, indicating the use of affected product may cause serious adverse health consequences, including death.
TAVR Procedures Increasing In Popularity, Raising Concerns
The use of transcatheter aortic valve replacement (TAVR) procedures is becoming an increasingly popular alternative to open heart surgery in the medical community, even though the durability and true health risks associated with procedures remains uncertain.
Artificial heart valves are widely used to treat aortic stenosis, a narrowed heart valve. The TAVR procedure was originally targeted at older patients, when aortic stenosis is most common. However research has shown the artificial heart valves have not been on the market long enough for people to know how long they’ll function in patients, which raises concerns in the frequency the products have been used in younger patients.
Despite the lack of long-term data regarding durability, companies continue to market the valves and procedure to younger patients as a less invasive option. However, doctors, researchers, and even the manufacturers who make the valves cannot say for certain if the devices will last the lifetime of a younger patient.