Medical device giant Medtronic will update the instructions for its advanced heart valve delivery system following its reported involvement in 19 patient deaths.
The Minneapolis Star Tribune reports that the company — which operates out of the Twin Cities but is officially headquartered in Ireland — sent a letter to doctors urging them to use additional care when using the EnVeo R.
The EnVeo R is used in minimally invasive procedures to implant Medtronic’s Evolut R valve through blood vessels. It treats aortic stenosis — a narrowing of the aortic valve that can lead to fainting, irregular heartbeat, and heart failure.
The system also allows high-risk patients to avoid open-heart surgery — along with longer and more expensive recovery times — and is considered high-growth for Medtronic and other medical device companies.
(Image credit: Medtronic)
Although the EnVeo system has been safely used in tens of thousands of procedures, University of Minnesota cardiologist Gregory Helmer tells the paper that the company noticed a higher mortality rate in “patients with vascular trauma.”
Internal data showed 39 reports of damage to patients’ arteries — including 19 deaths attributed to severe blood vessel trauma.
The new instructions direct doctors to use particular caution in at-risk patients and urges them not to force the device into blood vessels if they encounter resistance during the procedure.
The voluntary revisions technically qualify as a recall. Even so, the Star Tribune reported the device is not considered defective and will not be returned to the company.
“Sometimes people, if they meet resistance, they just push harder,” Helmer adds. “And really what you need to do is back off.”
