Abbott MitraClip Warning Issued By FDA Over Clip Lock Malfunctions

Federal regulators warn problems with Abbott MitraClip devices, used during heart valve repair surgeries, may malfunction and result in serious injuries.

The U.S. Food and Drug Administration (FDA) issued the Abbott MitraClip warning for healthcare providers on September 8, indicating there have been reports of clip lock malfunctions, sometimes resulting in instances of mitral regurgitation; a backflow of blood into the heart.

The MitraClip Delivery System is a heart valve repair device that is used to treat mitral regurgitation, a condition where the mitral valve of the heart does not close completely causing blood to leak into the left atrium. It was first approved in 2013, for patients with significant symptomatic mitral regurgitation and who face high risks for surgery. The system allows the surgeon to access the heart and the mitral valve without the need for open heart surgery.

In 2019, the MitroClip device was approved to treat patients with structurally normal mitral valves who develop heart failure symptoms and moderate-to-severe mitral regurgitation due to left heart enlargement and diminished function. It is currently the only percutaneous, implanted through the skin, repair device approved in the U.S. to treat mitral regurgitation.

According to the FDA warning, Abbott MitroClip malfunctions lead to the clips opening when they should be locked, or moving unexpectedly after placement. This can result in 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.

Abbott issued an Urgent Medical Device Correction Letter (PDF) to health care providers the same day as the FDA’s warning, indicating the events occur in roughly 1.3% of MitraClip procedures done with all device models.

The problem reportedly affects the MitraClip G4 Clip Delivery System and the MitraClip NTR/XTR Clip Delivery System. The warning affects all MitraClip lot numbers.

No MitraClip Recall to Date

There has been no MitraClip recall associated with the warning, and the FDA indicates the potential benefits of the MitraClip device still outweigh the potential risks, and the agency indicates in most cases the MitraClip can be used safely. The agency indicates that there have been no adverse patient outcomes caused by the clip lock malfunctions so far, although some did require non-urgent surgical conversions.

The FDA is urging healthcare providers to be aware of clip lock malfunctions before or after deployment. The agency may also classify the urgent medical device correction notice issued by Abbott as a recall at a later date.

The agency says it is working with Abbott to evaluate reports of clip lock malfunctions and identify strategies to combat the problem. The agency also says it is monitoring reports of adverse events linked to the problem.

Adverse events linked to Abbott MitraClip Delivery Systems should be reported to the FDA using the MedWatch Adverse Event Reporting program.