Medtronic Warns of a TAVI Implantation Problem

The medical device giant has provided extra warning to doctors when it comes to the potentially deadly consequences of using too much force with the delivery system for the CoreValve Evolut R.

Chris Newmarker

Medtronic has issued a worldwide warning to doctors to avoid using too much force while operating the Enveo R delivery system used with the CoreValve Evolut R transcatheter aortic valve implantation system. 

Dublin, Ireland-based Medtronic, which is run operationally out of the Twin Cities, has discovered that out of thousands of procedures, 19 patients died after damage to their arteries during the implantation procedure. 

"While reports of vascular trauma during transcatheter aortic valve replacement (TAVR) procedures are infrequent (0.136% based on units distributed as of May 2016), events have been severe and in certain cases, resulted in patient death. We are taking precautions necessary to help mitigate the occurrence of such trauma," Medtronic spokesperson Joey Lomicky told Qmed via email on Thursday. 

FDA is listing the event as a Class 2 recall, but Medtronic is not asking doctors to return the thousands of Enveo R delivery systems it has distributed around the world. The company is instead updating instructions and training programs to warn doctors not to force passage, because "increased resistance may indicate a problem and forced passage may result in damage to the device and/or harm to the patient."

"It's pretty common sense, but I think they're just trying to increase awareness of proper technique," Gregory Helmer, MD, director of the University of Minnesota's TAVR program, told the Star Tribune of Minneapolis, which broke the story.

"Sometimes people, if they meet resistance, they just push harder. And really what you need to do is back off," Helmer said. 

Medtronic entered the U.S. transcateter heart valve market with its CoreValve system in early 2014.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Image courtesy of Medtronic]