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On Sept. 8, Abbott issued an urgent medical device correction. It informed providers of an increased rate of reports of clip lock malfunctions. Users observed malfunctions both before and after clip deployment.

The FDA notice said the events appear to occur in approximately 1.3% of MitraClip procedures. Users observed such events with all device models.

Abbott designed MitraClip to treat mitral regurgitation (MR). In the event of a clip lock malfunction, patients are at risk of ineffective treatment for MR. It also increases the potential need for additional interventions, leading to risks such as bleeding, implant complications and lengthened procedure times.

The majority of reported malfunctions for MitraClip were not associated with adverse patient outcomes. Based on available data, FDA said it believes the probable benefits of the system outweigh the probable risks.

As such, FDA recommends that healthcare providers remain aware of the potential for clip lock malfunctions. The agency said it is monitoring reports of adverse events related to the issue. Abbott is producing new lots of devices to mitigate the issue.

Abbott’s MitraClip first received FDA approval for treating MR in 2013. It treats patients with abnormalities of the mitral valve and those for whom risks for surgery are prohibitive.

The device received a new indication in 2019. It allowed for the 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.

According to FDA, MitraClip is the only percutaneous repair device approved in the United States to treat patients with MR.

Filed Under: Cardiac Implants, Cardiovascular, Featured, Food & Drug Administration (FDA), Implants, News Well, Regulatory/Compliance, Replacement Heart Valves, Structural Heart Tagged With: Abbott, FDA

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