Medtronic Hit with Serious CoreValve-related Recall

Qmed Staff

August 7, 2015

2 Min Read
Medtronic Hit with Serious CoreValve-related Recall

A little more than a month after the medtech giant received FDA approval for its CoreValve Evolut R valve, a delivery device related to the product is the subject of a Class I-level recall.

Qmed Staff

Medtronic EnVeo R

FDA has given its highest recall designation to a recent Medtronic recall of the EnVeo R loading system for the company's CoreValve Evolut transcatheter aortic valve device.

Medtronic recalled specific lots of the EnVeo R device last month citing "particulate being observed in a small number of cases,"

The company had received eight complaints related to the problem--two of which were related to particulate observed in the packaged kits while the remaining six were observed during the valve loading procedure, according to a recall letter posted on the website of Germany's  Federal Institute for Drugs and Medical Devices.

Medtronic reports that no patients have been adversely affected by the problem, which FDA says involves 6912 units in commerce, 540 of which were being used in clinical trials in the United States.

The urgent field safety notice sent to its customers, however, acknowledges that the problem could potentially lead to particulate matter being accidentally deployed during the implantation of the Evolut device, potentially causing a blood clot. FDA has designated the recall as Class I.

Medtronic is asking customer that have received the affected lots return them to the manufacturer. A Medtronic spokeswoman confirmed that the company has already removed affected EnVeo R loading systems from the market, and resolved the problem with the loading systems through a manufacturing process improvement.

The EnVeo R system has won accolades in the DuPont packaging innovation awards.

The CoreValve Evolut R device was approved by FDA in June. It is the only device of its kind that physicians can recapture and reposition in patients.

Since the FDA initially approved Medtronic's CoreValve in early 2014 for us on patients at extreme or high risk for open-heart surgery. Since then, the agency has also permitted the device to be used for so-called "valve-in-valve" (VIV) replacement, in which the valve is deployed inside a failing artificial heart valve.

The CoreValve's chief competitor is Edwards Lifescience's Sapien line of transcatheter heart valves.

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