After 19 deaths, Medtronic cautions docs on aortic valve insertion

EnVeo R Delivery Catheter system--Courtesy of Medtronic

Medtronic is revamping the instructions for a delivery system used to insert an aortic valve after an internal analysis found 39 patients with blood vessel damage, among whom 19 died.

In a letter publicized Tuesday, the device giant warned customers worldwide about the risk of vascular trauma in transcatheter aortic valve replacement (TAVR) procedures involving the EnVeo R Delivery Catheter system. It provided recommendations for minimizing this risk, such as not “forcing” the device if doctors encounter resistance and using live-motion X-rays to identify twisting or calcified blood vessels, the Star Tribune reported.

The EnVeo R system is used to place Medtronic’s ($MDT) CoreValve Evolut R aortic valve. The system is only recapturable and repositionable TAVR : once placed, it can be retrieved and moved in reverse using the delivery catheter. The Evolut R won FDA approval in June 2015. Just two months later, Medtronic recalled more than 6,000 units of the EnVeo system due to the presence of particulate matter.

Virtual Event

Virtual Clinical Trials Online

This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance.

The FDA has classified Medtronic’s action as a Class II recall, but no products are actually being recalled as they are not defective. Instead, Medtronic will update the instructions for use. The action affects 7,300 EnVeo R systems in the U.S. and about 24,000 worldwide.

In the grand scheme of things, vascular damage was not a common occurrence. In fact, other types of trauma stemming from the procedure, such as aortic disruption, occur more frequently, the Star Tribune reported. Nonetheless, given the nearly 50% fatality rate of vascular trauma from this procedure, raising awareness of “proper technique” makes sense, said Gregory Helmer, cardiologist and director of the University of ­Minnesota transcatheter aortic valve replacement program, as quoted by the Star Tribune.

“They’re bringing this to light basically to just make everyone aware and improve the overall safety of the TAVR procedure,” Helmer said.

- here's the Star Tribune story
- read more from the FDA

Related Articles:
Medtronic to start TAVR trial for aortic stenosis patients at low risk of surgical mortality
FDA OKs use of Medtronic's CoreValve TAVR on end-stage renal disease patients
Medtronic recalls CoreValve TAVR component due to presence of particulate matter
Medtronic strikes back with FDA approval of its second-gen TAVR

Read more on

Suggested Articles

Since Genentech scored a speedy review of its spinal muscular atrophy drug, the company has submitted more data, leading the FDA to extend its review.

Designed by OraSure, the test would detect the novel infection behind COVID-19 as well as all coronaviruses that can lead to respiratory disease.

President Donald Trump has asked “leading” pharma companies working on COVID-19 treatments to offer help to U.K. Prime Minister Boris Johnson.