Medtronic has announced the voluntary recall of the EnVeo R Loading System, a component in the CoreValve Evolut R system for transcatheter aortic valve replacement (TAVR), less than two months after the device received Food and Drug Administration (FDA) approval.
The recall came after Medtronic received eight reports of the presence of particulates in the EnVeo R Loading System. The particulates could “be transferred to the transcatheter aortic valve and released into the patient’s vasculature,” potentially resulting in clot formation and blockage of the valve, Medscape reports.
In two of the reports, the particulates were noticed in the packaged kits. In the remaining reports, the particulates were seen by someone who was loading the bath. No injuries or adverse events have been reported to date, Medtronic said in its letter notifying customers of the problem. A Medtronic representative said none of the affected loading systems were released commercially in the U.S. and they were being used only in clinical trials. All units have now been removed from the market, Medscape reports.
The Evolut device received FDA approval in June for transaortic valve replacement (TAVR) in patients with severe aortic stenosis — a narrowing of the aortic valve. Traditional open-heart surgery is too risky for these patients. TAVR is a fairly new heart procedure, a minimally invasive technique to repair the aortic valve without removing the old valve, the American Heart Association explains. Particulates in the loading system could be transferred to the patient’s blood stream, leading to a blockage that could have serious health consequences, Medtronic said in its letter to customers.
The recalled EnVeo R units are the EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, and LS-EnVeoR-2629-C. The cardiovascular valve delivery system is for use with the Medtronic CoreValve Evolut R system. Medtronic notified health care professionals about 6,912 EnVeo R Loading System units in the field, of which 540 were in the U.S. Only certain lots of the loading system were affected and Medtronic told customers how to contact the company about those. But, the letter said, “Medtronic is not making any special patient management recommendations; patients should continue to be managed in accordance with your standard patient-management protocol.” According to a Medtronic representative, the particulate issue has “now been resolved with the introduction of a process improvement in manufacturing,” Medscape reports.
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 and to inform any other facilities to whom they may have sent units. The FDA recall notice said customers should complete the customer confirmation certificate and to email RS.CFQFCA@Medtronic.com or fax Medtronic at (651) 367-0612 to the attention of Customer Focused Quality for further instructions.