Abbott Vascular Voluntarily Recalls MitraClip to Review Delivery System

May 9, 2011—TheHeart.org’s Heartwire reported that Abbott Vascular (Santa Clara, CA) has confirmed that the company has initiated a voluntary recall of the MitraClip system because of problems with the delivery system. The MitraClip is used for percutaneous repair of the mitral valve in patients with severe mitral regurgitation.

According to Heartwire, Abbott Vascular advised that there was no cause for concern for patients with previously implanted MitraClip devices and that the company has instigated the recall “to ensure that patient safety is kept first and foremost.” The company stated that it is conducting a detailed investigation into the problem and will make minor modifications to the delivery catheter. Abbott stated that it hopes to resume shipments as soon as possible.

An Abbott Vascular spokesperson stated that there have been three incidents in which a radiopaque ring that is part of the delivery system has become detached when the catheter was withdrawn. In one case, the ring was removed percutaneously, and in the other two cases, surgical intervention had to be used. Two of the patients affected have now been discharged home, but one patient in Italy died a few days after surgical retrieval of the ring. The Abbott spokesperson said that it is not known whether the death was related to the procedure, but noted that the MitraClip device was typically used in very ill patients with multiple comorbidities who were generally not suitable for surgery

As Heartwire noted, the MitraClip device has been placed in approximately 3,000 patients worldwide. The device has been available in Europe since 2008 and is now available in Australia, Singapore, Israel, and Turkey. Abbott said that use of the device had been taken up slowly because physicians had to undergo specialized training to learn how to place it. The MitraClip is not yet approved in the United States, but it is being used on a limited “continued-use” preapproval basis by the centers involved in the pivotal phase 3 clinical trial EVEREST II.

Source: Sue Hughes. MitraClip recalled due to problem with delivery system. theheart.org [Clinical Conditions > Interventional/Surgery]; May 9, 2011. Accessed at http://www.theheart.org/article/1223259.do on May 9, 2011.