FDA Warns Against Abbott MitraClip Malfunctions

The FDA yesterday released a statement to healthcare providers regarding potential clip lock malfunctions with Abbott’s MitraClip Clip Delivery Systems.

MitraClip is a heart valve repair device intended to treat mitral regurgitation. It was first approved in 2013 to reduce MR in patients whose disease has significant symptom abnormalities of the mitral valve and are contraindicated for mitral valve surgery. In 2019, Abbott obtained FDA approval for an additional indication of the device. The new indication included treatment of patients with structurally normal mitral valves who develop symptoms of heart failure and experience moderate-to-severe or severe MR due to left heart enlargement and diminished function, despite treatment with optimal medical therapy.

Abbott originally issued an urgent medical device correction to inform healthcare providers about an increased rate of reports of clip lock malfunctions before and after clip deployment. The malfunctions have been observed in all device models and in approximately 1.3% of MitraClip procedures. Risks of malfunction include ineffective MR treatment, potential need for additional interventions contributing to increased procedural issues like bleeding, complications with implanting additional clips, and longer procedural times.

Despite these events, the FDA wrote that the probable benefits of the device continue to outweigh probable risks for the approved use indications. The administrations said it is working with Abbott to report malfunctions and identify other potential contributing factors and mitigation strategies. Currently, the FDA recommends healthcare providers review the recall notice from Abbott discussing the MitraClip and be aware of the potential malfunctions before and after clip deployment. Additionally, read and follow the instructions for use and recommendations provided in the recall notice to minimize the chances of clip failure.

“These include recommendations about procedural steps for implant positioning, locking sequences, establishing clip arm angle, preparation for clip release, and avoiding excessive force and manipulation when unlocking the clip during device preparation and during the procedure,” according to the FDA.

The administration urges healthcare providers to report any adverse events or suspected adverse events with the device through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.