Medtronic Recalls Heart Device Loading System Due to Particulates in Packaged KitsAug 10, 2015
Medtronic has announced the voluntary recall of its EnVeo R Loading System, which is used with its CoreValve Evolut R system for transcatheter aortic valve replacement (TAVR).
The manufacturer received eight reports about the presence of particulates in the EnVeo R Loading System, which "has the potential to be transferred to the transcatheter aortic valve and released into the patient's vasculature." Two of the reports involved particulates observed in the packaged kits, while the other six involved particulates observed in the loading bath, Medscape reports. No adverse events have been reported to date. A Medtronic representative said none of the affected loading systems were released commercially in the U.S. and were being used only in clinical trials. All have now been removed from the market.
The Evolut device was approved earlier this summer for transaortic valve replacement (TAVR) in patients with severe aortic stenosis - a condition where the aortic valve narrows - and for whom surgery is too risky. The American Heart Association explains that TAVR, a fairly new procedure, is a minimally invasive procedure that repairs the valve without removing the old valve. The presence of particulates could potentially lead to a blockage in the bloodstream, Medtronic said in its letter to customers.
The affected 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.
The FDA designated this recall Class 1, the most serious recall category. Class 1 means that there is a "reasonable probability" that use of the product can cause serious health consequences or even death.
The Urgent Medical Device Recall Letter instructed customers to complete the customer confirmation certificate and to email RS.CFQFCA@Medtronic.com or fax to Medtronic at (651) 367-0612 to the attention of Customer Focused Quality for further instructions.