(Reuters) – The U.S. Food and Drug Administration on Thursday alerted healthcare providers about a potential clip lock issue with Abbott Laboratories’ MitraClip device used to stop heart valve leakage.
The medical device treats mitral regurgitation, a 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. MitraClip was first approved in 2013.
The FDA said the malfunctions appear to occur in about 1.3% of MitraClip procedures and have been observed with all device models.
Abbott said it had received increased rate of reports of the devices failing to “establish final arm angle” or “clip opening while locked”.
The company said it has identified the cause of the clip lock malfunction and was working on producing new lots of the device with updated manufacturing processes and raw materials to mitigate the issue.
The health regulator said majority of the reported malfunctions have not been associated with “adverse patient outcomes” and based on the available data it believes benefits continue to outweigh the risks for use of the device.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Shounak Dasgupta)
