Edwards’ SAPIEN M3 delivery system linked to patient death in FDA alert

An issue with the delivery component of Edwards’ SAPIEN M3 TMVR system has been associated with one patient death and one serious injury as of 5 October. An issue with the delivery component of Edwards’ SAPIEN M3 TMVR system has been associated with one patient death and one serious injury as of 5 October. Edwards’ SAPIEN M3 mitral valve replacement system obtained FDA clearance in December 2025. Credit: Tada Images The US Food and Drug Administration (FDA) has conveyed a ‘potentially high-risk’ issue affecting certain mitral valve delivery systems marketed by Edwards Lifesciences, which have been linked to a patient…

Source: Medical Device Network