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Product Name: MitraClip Clip Delivery System
Company: Abbott Vascular
Abbott Vascular initiated a voluntary safety notice regarding the MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device, according to an Abbott press release. The safety notice was issued after the company received 9 reports of the user (a surgeon or interventional radiologist) being unable to separate the implantable Clip from the delivery system.
“Abbott’s investigation determined that the delivery system’s ‘arm postiioner’ 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 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.”
The U.S. Food and Drug Administration (FDA) has classified this safety notice as a Class I Recall. Abbott is not removing product from commercial distribution. 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.
Commercial Clip Delivery Systems with lot numbers 50714U1 and greater are within the scope of this action.
What is the MitraClip?
The MitraClip Clip Delivery System (MitraClip CDS) consists of implant catheters and the MitraClip device. It is intended to treat patients with degenerative mitral regurgitation (a leaky heart valve)who are too high a risk for surgery.
- The MitraClip device is inserted by a catheter through the femoral vein and guided into the heart.
- It is positioned by grasping both leaflets of the mitral valve (a valve in the heart).
- The MitraClip device, which is a permanent implant that attaches to the mitral valve leaflets, is then supposed to be left in place and the delivery catheter is supposed to be removed, but in these 9 cases that did not happen.