For Immediate Release
February 26, 2016
Abbott Vascular Representative
Abbott has 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 a small number of reports involving MitraClip Delivery Systems where the user was unable to separate the implantable Clip from the delivery system. Presently, there are 3,534 devices on the market (1,288 in the United States and 2,246 outside the United States). 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% 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. (more…)