The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
September 8, 2022
The U.S. Food and Drug Administration (FDA) is alerting health care providers about potential clip lock malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott.
On September 8, 2022, Abbott issued an Urgent Medical Device Correction to inform health care providers about the issue. An increased rate of reports of clip lock malfunctions has been 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 in the event of a clip lock malfunction includes ineffective treatment of mitral regurgitation (MR) and the potential need for additional interventions contributing to increased procedural risks such as bleeding, complications with implanting additional clips, and longer procedural 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 the associated risks, the FDA believes that the probable benefits of the MitraClip device continue to outweigh the probable risks for the approved indications for use. The FDA is issuing this letter to ensure you are aware of the manufacturer’s recall notice and recommended actions.
The FDA recommends that health care providers:
The MitraClip Clip Delivery System is a heart valve repair device that is intended to treat MR. MitraClip was first approved in 2013 to reduce MR in selected patients:
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.
MitraClip is currently the only percutaneous (implanted through the skin without open surgery) repair device approved in the United States to treat patients with MR.
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 reports of adverse events related to the issue.
The FDA will keep health care providers and the public informed if new or additional information becomes available.
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with Abbott MitraClip Delivery Systems.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).
The .gov means it’s official.