Minnesota-based heart device maker Medtronic PLC has warned doctors worldwide to be especially careful when using the EnVeo R delivery system to insert the Evolut R aortic valve after 19 patients died from severe blood-vessel trauma, according to an article in the Minneapolis Star Tribune.
Medtronic also informed doctors that it is voluntarily updating its instructions for using the EnVeo R delivery system. The new instructions will be implemented in future physician-training programs, and doctors who have already been trained on use of the device will be told about the updates.
The new instructions caution doctors not to “force” the delivery system if they encounter resistance in blood vessels, and to pay close attention to patients who may have complex or weakened arteries. The steps are meant to minimize the risk that the device will puncture or damage a blood vessel during a procedure.
In a recent internal analysis of global data, Medtronic uncovered 39 cases in which patients sustained damage to their arteries when doctors used the EnVeo R system. Although this number was considered low in the context of tens of thousands of valve replacements, the complication is often lethal—19 of the patients died.
With an average price of approximately $30,000, Evolut R aortic valves are more expensive than others but require less recovery time than traditional surgery. In the United States, the valves are approved for use only in patients at high risk of complications from traditional surgery, which means that the patient population tends to be older and more frail.
Technically, the FDA classified Medtronic’s announcement as a medium-severity (class II) recall, but no product is actually being sent back to the company because the device isn’t considered defective. Medtronic transcatheter valves that have been successfully implanted are not affected by the recall.
Source: Minneapolis Star Tribune; August 18, 2016.