The US Food and Drug Administration (FDA) has issued a warning to healthcare providers about potential clip lock malfunction associated with Abbott’s MitraClip device, which is used for fixing heart valve leakage.
First approved in 2013, the MitraClip Clip Delivery System is a heart valve repair device intended to cure mitral regurgitation (MR).
An Urgent Medical Device Correction issued by Abbott on Thursday mentioned that the issue was observed in about 1.3% of MitraClip procedures. These have been seen with all device models, said the company.
According to Abbott, there have been more complaints about the devices’ failure to establish final arm angle (EFAA) and clip opening while locked (COWL).
The medical device maker claimed to have found the causes of the EFAA and COWL issues. Following this, the company is said to be working on producing new batches using updated manufacturing processing and raw material to address the issues.
According to the FDA, the majority of reported faults have not been connected to adverse patient outcomes. Based on the data available and the related risks, the likely benefits of the MitraClip device are more than the possible risks for the approved indications, said the FDA.
The regulator stated: “The FDA is working with the manufacturer to continue to evaluate reports of clip lock malfunctions and identify other potential contributing factors and mitigation strategies. The FDA will continue to monitor reports of adverse events related to the issue.
“The FDA will keep health care providers and the public informed if new or additional information becomes available.”
A new indication for the heart valve repair device was approved by the FDA in 2019. Through this, the device can be used for the treatment of patients who develop heart failure symptoms and moderate-to-severe or severe MR because of left heart enlargement and reduced function, in spite of treatment with optimal medical therapy.
In September 2020, Abbott received CE mark approval for the fourth-generation MitraClip transcatheter mitral valve repair system.
