Medtronic warns doctors on heart valve delivery system after 19 deaths reported

Heart device maker Medtronic PLC is warning doctors worldwide to use extra care when inserting a popular new kind of heart valve in some patients, following reports of 19 deaths from severe blood vessel trauma.

In a letter publicized late Tuesday, the Minnesota-run company informed doctors that it is voluntarily updating its instructions for using the minimally invasive EnVeo R delivery system, which doctors use to implant the Evolut R aortic valve in the heart. The device is used to treat a narrowing of the valve called aortic stenosis, which can lead to heart failure, irregular heart beats and fainting.

An internal analysis of global Medtronic data recently turned up 39 cases in which patients sustained damage to their arteries while doctors used the EnVeo R system. Although the number of incidents was considered low in the context of tens of thousands of valve replacements, the complication is often lethal — 19 of those patients died.

http://www.startribune.com/medtronic-warns-doctors-on-valve-delivery-system/390518901/