Abbott is recommending that physicians who implant the MitraClip Delivery System receive training following reports of users being unable to separate the implantable clip from the delivery system.
The company also is updating its instructions for use regarding the deployment sequence of the device, which is used to treat people with degenerative mitral regurgitation, according to a safety notice posted by the FDA Feb. 26. The agency has designated the notice as a Class 1 recall.
Abbott has received nine medical device reports of malfunction, or about 0.17 percent of the product that was on the market at that time prior to issuing the field safety notice, says company spokesman Jonathon Hamilton.
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, the notice says.
All of these cases 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, says the notice. There was one patient death in these cases as a result of severe comorbidities following surgery. — Jonathon Shacat