FDA Announces Malfunctions in Abbott’s MitraClip Device

Mitral regurgitation typically requires a heart valve repair or replacement. Abbott’s MitraClip Clip Delivery System was approved by the FDA in 2013 as a heart valve repair device. However, on September 8, 2022, the FDA announced that Abbott issued an urgent medical device correction in light of recently increased malfunctions.

According to the Mayo Clinic, mitral regurgitation “is a type of heart valve disease in which the valve between the left heart chambers doesn't close completely, allowing blood to leak backward across the valve. It is the most common type of heart valve disease (valvular heart disease).”

If left untreated, mitral valve regurgitation can lead to a heart murmur, arrhythmia, dyspnea, palpitations, and edema.

The MitraClip Clip Delivery system was initially approved for use in patients with symptomatic mitral regurgitation and heart failure systems or patients “whose risks for mitral valve surgery are prohibitive.”

The FDA press release states, “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.”

The device malfunction occurs in 1.3% of procedures where the clip lock fails both before and after clip deployment — a trend that has been consistent in all device models.

“The potential risk to patients in the event of a clip lock malfunction includes ineffective treatment of mitral regurgitation and the potential need for additional interventions contributing to increased procedural risks such as bleeding, complications with implanting additional clips, and longer procedural times,” states the FDA release.

The FDA recommends that healthcare professionals thoroughly read the recall notice issued by the company and make themselves aware of the potential for mishap. Additionally, the recall notice includes detailed instructions on device use from Abbott to minimize the risks.

Any device failures, adverse events, or suspected events should be reported to the company and the FDA.

The FDA is currently working with Abbott to determine the extent of malfunctions, potential contributing factors, and mitigation strategies. Providers who use this device should monitor the FDA website for additional updates.