Recently Approved Medtronic Heart Valve Device under Class 1 RecallAug 11, 2015
The recall of the EnVeo R loading system has been designated a Class 1 recall, which is the FDA's most serious recall category. In a Class 1 recall, use of the affected product could result in serious health consequences or death. The recalled loading system is used with Medtronic's CoreValve Evolut transcatheter aortic valve device, Qmed reports.
The Evolut device was approved in June for transaortic valve replacement (TAVR) for patients for whom a standard open-heart procedure is too risky. TAVR is used to treat severe aortic stenosis - a narrowing of the aortic valve. The American Heart Association explains that TAVR is a minimally invasive procedure that repairs the valve without removing the old valve. The presence of particulates in the loading bath could lead to a blockage in the patient's bloodstream, Medtronic said in its letter to customers.
Medtronic announced the recall of specific lots of the EnVeo R device in late July. The company said "particulate being observed in a small number of cases." Before initiating the recall, the company had received eight complaints related to the problem out of 7,347 potentially affected units. Two of the complaints were about particulates observed in the packaged kits and the remaining six involved particulates observed during the valve loading procedure, according to the recall letter. Medtronic reports that no patients have been adversely affected by the problem. The FDA said the problem involves 6,912 units, 540 of which were being used in clinical trials in the United States.
The Urgent Field Safety Notice sent to customers contains a full list of the lot number of the affected devices. The FDA has designated this recall as Class 1, the agency's most serious recall category. In a Class 1 recall there is a "reasonable probability" that use of the recalled device could cause serious health consequences or even death.
Medtronic is asking customers who have the affected lots to immediately remove them from inventory and return them to the manufacturer. A Medtronic spokeswoman confirmed that the company has already the removed affected EnVeo R loading systems from the market, and resolved the problem with the loading systems through a change in the manufacturing process. The issue does not affect other Medtronic devices or other components of the Evolut R TAV system, according to the company's letter.
The FDA initially approved Medtronic's CoreValve in early 2014 for use on patients at extreme or high risk for open-heart surgery, Qmed reports. The FDA has also permitted the device to be used for so-called valve-in-valve (VIV) replacement, in which the valve is deployed inside the patient's failing artificial heart valve.