U.S. Food and Drug Administration (FDA) is alerting health care providers about potential clip lock malfunctions with MitraClip Delivery Systems manufactured by Abbott.
An increased rate of reports of clip lock malfunctions has been observed before and after clip deployment. These events appear to occur in approximately 1.3% of MitraClip procedures and have been observed with all device models, said Abbott.
The MitraClip Clip Delivery System is a heart valve repair device that is intended to treat Mitral regurgitation (MR), a disorder in which the mitral valve on the left side of the heart does not close properly.
MitraClip was first approved in 2013 to reduce MR in selected patients whose significant symptomatic MR and heart failure symptoms result from abnormalities of the mitral valve commonly known as primary or degenerative MR); and whose risks for mitral valve surgery are prohibitive.
In 2019, a new indication for the device was approved to include treatment of patients with structurally normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe MR due to left heart enlargement and diminished function (commonly known as secondary or functional MR) despite treatment with optimal medical therapy.
MitraClip is currently the only percutaneous (implanted through the skin without open surgery) repair device approved in the United States to treat patients with MR.
