Mitraclip Recalled Due to Problems With Delivery System


May 09, 2011

May 9, 2011 (Abbott Park, Illinois) — Abbott has confirmed to heartwire that it has initiated a voluntary recall of the MitraClip system because of problems with the delivery system. The clip is used for the percutaneous repair of the mitral valve in patients with severe mitral regurgitation.

An Abbott spokesperson told heartwire that there have been three incidents in which a radiopaque ring (part of the delivery system) has become detached when the catheter was withdrawn.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, but one patient (in Italy) died a few days after surgical retrieval of the ring.

The spokesperson said it is not known whether the death was related to the procedure, but he added that the MitraClip device was typically used in very ill patients with multiple comorbidities who were generally not suitable for surgery.

The company said it was conducting a detailed investigation into the problem and will make minor modifications to the delivery catheter, with shipments hoped to be resumed as soon as possible. It added that there was no cause for concern for patients with previously implanted MitraClip devices. Abbott said it has instigated the recall "to ensure that patient safety is kept first and foremost."

The MitraClip has been available in Europe since 2008. Abbott said its use had been taken up slowly as physicians had to undergo specialized training to learn how to place it. It is now also available in Australia, Singapore, Israel, and Turkey. It is not yet approved in the US, 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.

Abbott said the MitraClip had now been placed in about 3000 patients worldwide.


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