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.
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.
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