September 8, 2022

The United States Food and Drug Administration (FDA) is alerting healthcare providers to potential clip locking malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott.

On September 8, 2022, Abbott released an Urgent Medical Device Correction to notify healthcare providers of the issue. An increased rate of reporting clip lock malfunctions was 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.

The potential risk to patients with clip lock dysfunction includes ineffective treatment of mitral regurgitation (MR) and the potential need for additional interventions contributing to increased procedural risks such as bleeding, complications related to implantation of additional clips and longer procedure times. The majority of reported clip lock malfunction events have not been associated with adverse patient outcomes. Based on the available data on clip lock malfunctions and associated risks, the FDA believes that the likely benefits of the MitraClip device continue to outweigh the likely risks for the approved indications for use. The FDA is issuing this letter to ensure that you are aware of the manufacturer’s recall notice and recommended actions.

Recommendations

The FDA recommends that healthcare providers:

  • View Abbott’s Recall Notice for All MitraClip Clip Delivery Systems
  • Be aware of the potential for clip lock malfunctions before or after deployment with this device
  • Carefully read and follow the instructions for use and recommendations provided in Abbott’s recall notice to help minimize the risk of the clip not locking. These include recommendations on procedural steps for implant positioning, locking sequences, establishing clip arm angle, preparing for clip release, and avoiding force and excessive handling when unlocking the clip during device preparation and during the procedure.
  • Report any adverse events or suspected adverse events with MitraClip to the FDA, including clip lock malfunction events. See the Reporting Concerns to the FDA section below.

Background

The MitraClip Clip Delivery System is a heart valve repair device intended to treat MR. MitraClip was first approved in 2013 to reduce MR in certain patients:

  • whose significant symptoms of symptomatic MRI and heart failure result from mitral valve abnormalities (commonly referred to as primary or degenerative MRI); and
  • whose risks for mitral valve surgery are prohibitive.

In 2019, a new indication for the device was approved to include the treatment of patients with structurally normal mitral valves who develop symptoms of heart failure and moderate to severe or severe MRI due to an enlarged left heart and of a diminished function (commonly called secondary or functional). MR) despite optimal medical treatment.

MitraClip is currently the only percutaneous repair device (implanted through the skin without open surgery) approved in the United States to treat patients with MR.

FDA measures

The FDA is working with the manufacturer to continue to evaluate reports of clip lock malfunctions and identify other potential contributing factors and mitigation strategies. The FDA will continue to monitor adverse event reports related to this issue.

The FDA will keep health care providers and the public informed if new or additional information becomes available.

Reporting Issues to the FDA

The FDA encourages healthcare providers to report any adverse events or suspected adverse events encountered with Abbott MitraClip delivery systems.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Contact information

If you have any questions regarding this letter, contact the Division of Industry and Consumer Education (DICE).