Just weeks after receiving Food and Drug Administration (FDA) approval, Medtronic’s EnVeo R Loading System, used with the CoreValve Evolut R system for transcatheter aortic valve replacement (TAVR), has been recalled.
Medtronic said it had received eight reports of the presence of particulates in the EnVeo R Loading System. The particulates have “the potential to be transferred to the transcatheter aortic valve and released into the patient’s vasculature,” and this could result in formation of a clot and blockage of the valve, Medscape reports.
Two of the reports involved particulates observed in the packaged kits. In the other six reports, the particulates were seen by those loading the baths. Medtronic said to date there have been no reported injuries or adverse events. According to a Medtronic representative, none of the affected loading systems were released commercially in the U.S. They were being used only in clinical trials. All units have now been removed from the market, Medscape reports.
The Evolut device was approved in June for transaortic valve replacement (TAVR) in patients with severe aortic stenosis — a narrowing of the aortic valve—for whom open-heart surgery is too risky. The American Heart Association explains that TAVR is a fairly new heart procedure, a minimally invasive technique to repair the valve without removing the old valve. The presence of particulates in the loading system could potentially lead to a blockage in the bloodstream, Medtronic said in its letter to customers.
The recalled EnVeo R system works with the Evolut device. The affected units are the EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. The cardiovascular valve delivery system is for use with the Medtronic CoreValve Evolut R system. Medtronic sent letters to health care professionals about 6,912 EnVeo R Loading System units in the field, of which 540 were in the U.S. The letter explained that only specific lots of the loading system were affected and told customers how to contact the company. “Medtronic is not making any special patient management recommendations; patients should continue to be managed in accordance with your standard patient-management protocol,” the letter said. A Medtronic representative said the issue has “now been resolved with the introduction of a process improvement in manufacturing,” according to Medscape.
This recall has been designated as a Class 1 recall, the FDA’s most serious recall category. In a Class 1 recall, there is a “reasonable probability” that use of the product can cause serious health consequences or even death.
Medtronic has instructed customers to remove the recalled EnVeo R units from inventory. Customers should complete the customer confirmation certificate and email RS.CFQFCA@Medtronic.com or fax Medtronic at (651) 367-0612 to the attention of Customer Focused Quality for further instructions.