The MitraClip Delivery System is marketed as a minimally invasive device for use in treating people with degenerative mitral regurgitation. Following multiple malfunction reports involving their device in which the operator was unable to separate the implantable clip from its delivery system, Abbot began an investigation.
In the course of their investigation, the company discovered that the delivery system’s arm positioner had not been returned to the correct position by the operator during the deployment sequence. This operator error prevented the clip from detaching as it was intended to and resulted in surgical interventions to remedy the situation through removal of the system or replacement of the mitral valve.
One patient died due to severe comorbidities following their surgery.
According to Abbot, there are just over 3,500 of these devices on the market, with approximately a third of them in the United States. The company anticipates that any similar incidents in the future will also require surgery to correct the issue, but notes that patients who have already had the device implanted are not affected by this recall.
MitraClip delivery systems harboring lot numbers 50714U1 and greater, however, are included in it. The company has no plans to remove the product from commercial distribution, but does intend to reinforce operator knowledge of the deployment procedure. Thus, they issued a voluntary safety notice regarding the correct operation and deployment of the MitraClip Delivery System in hopes of preventing further operator errors.