The U.S. Food and Drug Administration (FDA) issued a second notification to health-care providers Friday stating that its preliminary analysis of long-term 5-year follow-up data from pivotal pre-market randomized trials of paclitaxel-coated products (paclitaxel-coated balloons (DCB) and paclitaxel-eluting stents (PES)) for peripheral artery disease identifies a concerning signal of increased mortality in patients treated with these devices.