Medtronic PLC has issued a warning regarding its minimally invasive EnVeo R delivery system, which is used to implant the Evolut R aortic valve in the heart. The company is urging doctors to take extra precautions when inserting the device, which is used to treat aortic stenosis, a narrowing of heart valves that can lead to heart failure, irregular heart rhythm and fainting. Medtronic issued the warning after 19 patients died of severe blood vessel trauma.
The alert involves 7,300 EnVeo R delivery systems in the United States and over 24,000 globally.
Medtronic said it was updating its instructions for using the delivery system, the company said in a letter to physicians. The company conducted an internal analysis of global data and found 39 cases where patients suffered damage to their arteries when doctors used the EnVeo R system. While 39 cases is low out of tens of thousands of procedures, the complication is often life-threatening; 19 people died.
“When they looked at patients with vascular trauma, they noticed that there is a high mortality rate,” said Dr. Gregory Helmer, cardiologist and director of the University of ¬Minnesota transcatheter aortic valve replacement (TAVR) program, according to Star Tribune. “They’re bringing this to light basically to just make everyone aware and improve the overall safety of the TAVR procedure.”
In the updated instructions, doctors are told not to “force” the system if they feel resistance in the blood vessels. They are also instructed to take special notice of patients with weakened or complex arteries. These measures will reduce the risk of the device puncturing or damaging the blood vessel wall. In a letter issued earlier this month, Medtronic warned that some patients are more susceptible to blood vessel damage.
The U.S. Food and Drug Administration (FDA) has technically classified Medtronic’s warning as a medium-severity recall, but no products are actually being sent back.
In its statement, Medtronic said the updated instructions would be included in upcoming physician-training programs. The updates will be sent to doctors who have already had the training.