MitraClip Mitral Valve Repair Safety Warning

Valves in the heart are important for ensuring one-way flow of blood. As a result of some diseases and also with aging these valves fail to function properly. This results in the back flow of blood typically referred to as regurgitation. Symptoms from this can be quite severe. As a result, surgical interventions are many times needed to correct the defective valve. Most surgeries require open-heart surgery which has a very lengthy recovery time. One new technique, the MitraClip Transcatheter Mitral Valve Repair system, attempts to correct the defective valve by inserting a clip (much like a paper clip) on the mitral valve that prevents blood from going in the wrong direction. In this procedure, a catheter or long plastic tube with the clip at the end are inserted into a blood vessel and directed to the heart. The mitral valve is located between the left atrium and the left ventricle. Once the catheter is in the left atrium the clip is attached to the mitral valve and then the catheter is released from the clip once it is in place and the catheter is removed.

While the system seems to be well designed, there have been recent problems reported with the system. In several reported cases, the interface between the catheter and the clip has malfunctioned resulting in an inability to separate the clip from the catheter. This resulted in patient death or further surgery to correct the problem. Therefore Abbott, the company that manufacturers this device, initiated a voluntary safety notice regarding the MetraClip Delivery System.