by John R. Fischer
, Senior Reporter | September 15, 2022
The FDA has issued a warning about Abbott Laboratories’ MitraClip device following the discovery of a potential clip lock issue.
Designed to treat mitral regurgitation, the solution was first approved in 2013 as part of the company’s structural heart portfolio. But Abbott has recently seen an uptick in reports saying that the device fails to “establish final arm angle” or has a problem with the “clip opening while locked,” according to Reuters
The FDA says the malfunctions occur in about 1.3% of MitraClip procedures and have been seen among all device models.
Abbott issued an urgent medical device correction on September 8, saying that it has identified the cause and will use updated manufacturing processes and raw materials to produce new lots of the device to mitigate the issue.
It estimates that the combined frequency of clip lock problems before deployment increased from 0.51% last year to 0.80% between February and July 2022, and from 0.28% to 0.50% after deployment in the same time period.
An unsuccessful MitraClip procedure can potentially lead to cardiogenic shock and death in some patients, but success rates have remained the same despite the malfunction rate increasing, says the company.
The issue has caused no adverse outcomes for patients in more than 90% of pre-deployment failures and 60% of post-deployment malfunctions, but some patients have experienced a recurrence of mitral regurgitation during procedures, reported MedTech Dive
And while no immediate conversions to open mitral valve surgery have been required, the persistence of the disease had led to the need for surgery later on in 0.53% of problem cases.
The FDA says it believes the benefits outweigh the risks for the device, based on available data.
The affected devices will remain on the market as Abbott works to mitigate the risk and reduce the malfunction rate.