The FDA has issued an early alert for certain delivery systems used with Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement system amid serious safety concerns.
The company sent a notice to customers on Oct. 5 recommending that they remove four specific lots of its Commander M delivery systems from locations where they are used or sold.
The SAPIEN M3 system received FDA approval last December. The affected delivery systems are used to deliver a replacement mitral heart valve through a patient's blood vessels without requiring open-chest surgery. The procedure is intended for certain patients with mitral valve disease who are not suitable candidates for other treatments.
Edwards said it has received three reports of balloons bursting during inflation. As of Oct. 5, the company had “reported one death and one serious injury associated with this issue,” according to the FDA notice.
“Potential injuries associated with balloon burst include embolism and inability to retrieve the device through the guide sheath, which may require additional intervention, including surgery,” the FDA added.
It’s been a tough year for the medtech. Back in January, Edwards was forced to abandon its proposed $945 million acquisition of heart valve developer JenaValve after a federal judge granted the Federal Trade Commission's request for an injunction blocking the deal.