Medtronic Cautions on EnVeo Catheter Risks

Medtronic has notified healthcare professionals about the potential for vascular trauma with the use of its EnVeo R Delivery Catheter System. The company says that while the reports of vascular trauma it has received have been infrequent, they have included serious outcomes, including 19 patient deaths.

The observed rate of vascular trauma of 0.136% is lower than the Transcatheter Valve Therapy registry reports in the Journal of the American College of Cardiology, which highlighted annular dissection and aortic disruption rates of 0.2% and 0.4% respectively, Medtronic says. “However,” it says, “due to the potential severity of these types of events Medtronic conducted a thorough investigation and identified recommendations to reduce the rate of vascular trauma events.” The notice covers patient anatomy recommendations and procedural use of the device.