FDA flags Edwards heart-valve delivery system issue after death, injury | Reuters

FDA warns of Edwards Lifesciences heart valve delivery system issue after death and injury

The U.S. FDA issued a warning about a potentially high-risk issue with certain Edwards Lifesciences delivery systems used in transcatheter mitral valve replacement, following one death and one serious injury. The agency said balloon bursts could obstruct blood vessels or prevent device retrieval, potentially requiring additional procedures including surgery.