Heart valve repair device by Abbot flagged for apparent malfunction

September 10, 2022
Heart valve repair device by Abbot flagged for apparent malfunction

Healthcare providers have been alerted to a potential clip-lock issue with one of Abbott Laboratories’ (Abbott) medical devices, by the US Food and Drug Administration (FDA). The device in question, MitraClip, is used to treat mitral regurgitation, or heart valve leakage.

Abbott’s MitraClip has been in use since 2013.

According to the FDA, clip-lock issues occurred in about 1.3% of MitraClip procedures and have been observed with all device models. However, a majority of these reports have not been associated with “adverse patient outcomes.”

Abbott has similarly received an increased rate of reports of the devices failing to “establish final arm angle” or “clip opening while locked,” and has identified the cause of the malfunction. Abbott is working on producing new lots of the device with updated manufacturing processes and raw materials to mitigate the issue.

Mitral regurgitation is a progressive condition in which the mitral valve of the heart does not close properly, causing blood leakage that can lead to stroke, heart attack, or even death.

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Category: Features, Technology & Devices

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