September 8, 2022

The US Food and Drug Administration (FDA) is notifying healthcare providers of clip locking defects in MitraClip Clip Delivery Systems manufactured by Abbott.

On September 8, 2022, Abbott One Emergency medical device repair To inform health care providers about the matter. Increased reports of clip lock crashes occurred before and after clip deployment. These events occurred in approximately 1.3% of mitraclip procedures and were observed in all device models.

Risks to patients in the event of clip lock failure include ineffective treatment mitral regurgitation (MR) and the need for additional interventions contribute to procedural risks such as bleeding, complications in implanting additional clips, and longer procedure times. Most reported incidents of clip lock failure were not associated with adverse patient outcomes. Based on data on clip lock malfunctions and associated risks, FDA believes that the potential benefits of the MitraClip device continue to outweigh the potential risks for the indications for its approved use. FDA issued this letter to ensure you are aware of the manufacturer’s recall notice and recommended actions.

Recommendations

The FDA recommends that health care providers:

  • Evaluate memory For all Mitraclip delivery systems from Abbott
  • Be aware of the possibility of clip lock malfunctions before or after using this device
  • Read and carefully follow the instructions for use and the recommendations provided in Abbott memory To help reduce the chance of the clip becoming locked. These include advice on implant placement, locking sequences, establishing clip arm angles, and prevention of excessive force and manipulation during device preparation and when opening the clip during the procedure.
  • Report any adverse events or suspected adverse events with MitraClip to the FDA, including clip lock failure. Look at that Reporting problems to the FDA room below.

Background

The MitraClip Clip Delivery System is a heart valve repair device intended for treatment. Mr.. Mitraclip was first approved in 2013 to reduce MR in selected patients:

  • Significant MR and signs of heart failure include the mitral valve (commonly known as primary or degenerative MR) and
  • The risk of mitral valve surgery is very prohibitive.

In the year In 2019, a new indication for the device was approved for the treatment of patients with symptoms of structural normal mitral valve heart failure and moderate to severe or severe MR with left heart enlargement and reduced function (commonly known as secondary or functional). MR) despite treatment with appropriate medical therapy.

The Mitra Clip is currently the only percutaneous (implanted through the skin without open surgery) approved to treat MR patients in the United States.

FDA actions

FDA is working with the manufacturer to review reports of clip lock failures and to identify other possible contributing factors and mitigation strategies. FDA will continue to monitor reports of adverse events related to the case.

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

Reporting problems to the FDA

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

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

Contact address

If you have questions about this letter, Contact the Department of Industry and Consumer Education (DICE)