On September 8, 2022 the U.S. Food and Drug Administration (FDA) alerted health care providers about potential clip lock malfunctions with Abbott’s MitraClip Clip Delivery Systems. According to Abbott’s Urgent Medical Device Correction, Abbott “has observed an increase in complaints regarding Clip locking malfunctions.” Malfunctions appear to occur in all device models, in approximately 1.3% of MitraClip procedures. An unsuccessful procedure could potentially lead to cardiogenic shock or death in some patients.
The MitraClip System was developed by a medical device company called Evalve Inc. Abbott acquired Evalve in 2009. After a European launch and a recall in 2011, MitraClip first received FDA approval for U.S. use in 2013, for degenerative mitral regurgitation (DMR). Chronic mitral regurgitation (MR) (the valve between the left atrium and the left ventricle does not close properly) is the most common cardiac valvular disease in the United States, with more than 4 million people suffering from moderate or severe MR. Medical therapy alleviates symptoms but does not cure it. Surgery is the most common corrective measure, but a large portion of patients are considered too high risk for surgery, due to advanced age or impaired left ventricle function.
According to Penn Medicine, MitraClip gives high-risk patients a non-surgical option for MR. UCSF Health describes a transcatheter mitral valve repair (TMVR) as a minimally invasive procedure for treating mitral valve regurgitation. The MitraClip is inserted through an artery by catheter and implanted in the valve, where it pulls the valve’s flaps into a more natural alignment.
Since 2019, MitraClip has also been approved for treatment of patients with secondary or functional mitral regurgitation (FMR). FMR is growing, from at least 2 million U.S. cases in 2000 to an expected 4 million by 2030. These patients have structurally normal mitral valves but develop heart failure symptoms and MR. Generally, secondary or functional MR is caused by left heart enlargement. Currently, MitraClip is the only percutaneous repair device approved to treat patients with MR.
If a clip lock malfunctions, however, a patient faces potentially ineffective treatment and potential need for additional interventions, causing complication and delays. The majority of reported clip lock malfunction events have not been associated with adverse patient outcomes, so the FDA continues to assess the probable benefits as outweighing the probable risks for approved indications.
The FDA has recommended steps for health care providers to minimize the likelihood of the clip failing to lock, including procedural steps for implant positioning, locking sequences, clip arm angle and excessive force.
According to CEO Robert Ford, Abbott has been investing in the expansion of MitraClip. The devices in question are not being taken off the market at this point, but Abbott is modifying its manufacturing process and advising physicians to take certain actions to mitigate risk.
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