The U.S. Food and Drug Adminstration issued a recall of MitraClip Delivery Systems on Feb. 29, 2016, for cardiology specialties. It is a minimally invasive device used to treat people with degenerative mitral regurgitation (DMR), a condition involving a dysfunction of the heart’s mitral valve. Presently, there are 3,534 devices on the global market, with a third of them being in the United States.
Abbott initiated a voluntary safety notice regarding the MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device. The company received reports involving MitraClip Delivery Systems where the user was unable to separate the implantable Clip from the delivery system. Abbott has received nine Medical Device Reports of malfunction.
Abbott’s investigation determined that the delivery system’s “arm positioner” was not returned to the required neutral position by the operator during the deployment sequence, subsequently preventing the Clip from detaching. All of these cases (0.17 percent incidence) resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem. There was one patient death in these cases as a result of severe comorbidities following surgery.
Commercial Clip Delivery Systems with lot numbers 50714U1 and greater are affected by this action. Individuals who have already had the device implanted are not affected by this action.
Abbott is requiring training of all MitraClip implanting physicians on the safety notice to ensure continued safe use of the device and is incorporating the safety notice’s deployment sequence in its Instructions for Use.