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.
More articles on medical devices:
FDA notifies 14 international medical device companies about regulatory violations
Are physicians and medical device reps too buddy-buddy?
Siemens, Insightec partner to expand access to Exablate Neuro technology
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.