Medtronic is cautioning physicians to be careful when using a popular new heart valve after 19 patients died from severe blood vessel trauma caused by the device, reports the Star Tribune.
Minneapolis-based Medtronic voluntarily updated instructions for the EnVeo R delivery system used to implant the valve after an analysis of internal company data found 39 cases in which patients received artery damage from the procedure, 19 of which died.
The device, called the Evolut R Transcatheter Aortic Valve, is used to treat aortic stenosis — a narrowing of the heart valve that can cause heart failure, irregular heart beat and fainting.
The updated instructions warn clinicians not to "force" the delivery system if they feel resistance in the blood vessels and retract the device if the tip unexpectedly bends.
The Food and Drug Administration classified Medtronic's warning letter released on Tuesday as a medium-severity recall, since the device is not considered defective and no product is being sent back to the company.
Medtronic plans to implement the new instructions into future physician-training programs and is informing already-trained physicians about the updated protocol.