Hospitals that perform transcatheter mitral valve replacement have been told to stop using four lots of an Edwards Lifesciences delivery system after reports of balloons bursting during procedures, a problem linked to one patient death and one serious injury. The FDA posted an Early Alert on Oct. 15 describing a potentially high-risk device issue.
The affected product is the Commander M delivery system used with the SAPIEN M3 Transcatheter Mitral Valve Replacement System, lots 67718561, 67804014, 67887043, and 67887044. Units with other lot numbers are not affected and can continue to be used, the FDA said.
