CDSCO issues medical device alert on Abbotts MitraClip Clip Delivery System

New Delhi, January 6, 2023 :

The Central Drugs Standard Control Organisation (CDSCO) has issued a medical device alert on US-based healthcare and medical devices firm Abbot's heart valve repair device MitraClip Clip Delivery System, which is intended to treat a heart condition that tends the mitral valve on the left side of the heart not to close properly.

The alert was following an increased rate of reports of clips failing to Establish Final Arm Angle (EFAA) and for events of Clip Opening While Locked (COWL), for which the manufacturer has alerted the US drug regulator in September, 2022.

The EFAA is a procedural step where the user intentionally attempts to open a locked clip to verify that the locking mechanism is engaged. This occurs during device preparation and prior to clip deployment. An EFAA failure occurs if the Clip opens during this verification step.

The COWL describes when the Clip Arm Angle increases post-deployment. In such cases, users observe a sloppage in the lock, resulting in an Arm angle greater than 10 degrees from the angle observed at deployment. This change in arm angle after deployment can be identified through fluoroscopy, said the Medical Device Alert.

When the clip is locked, the locking mechanism is designed to more fully engage as the grippers push down on the clip Arms. During a COWL event, the lock slips as the Clip Arms open by a given degree, it added.

Any person with mitral regurgitation (MR) - a disorder in which the mitral valve on the left side of the heart does not close properly and leak occurs from the valve since it does not close all the way - who has to be treated with the use of MitraClip G4 Clip Delivery System and MitraClip NTR/XTR Clip Delivery System are expected to be affected with the malfunction, said the alert.

However, the CDSCO noted that it has not received any complaints from the market on this issue.

The US Food and Drug Administration (FDA) has alerted the healthcare providers about potential clip lock malfunctions with the MitraClip Clip Delivery Systems manufactured by Abbott on September 8, 2022.

On September 8, 2022, Abbott issued an Urgent Medical Device Correction to inform health care providers about the issue, said the FDA alert.

"An increased rate of reports of clip lock malfunctions has been observed before and after clip deployment. These events appear to occur in approximately 1.3% of MitraClip procedures and have been observed with all device models," it said.

The potential risk to patients in the event of a clip lock malfunction includes ineffective treatment of MR and the potential need for additional interventions contributing to increased procedural risks such as bleeding, complications with implanting additional clips, and longer procedural times.

The majority of reported clip lock malfunction events have not been associated with adverse patient outcomes.

"Based on the available data on clip lock malfunctions and the associated risks, the FDA believes that the probable benefits of the MitraClip device continue to outweigh the probable risks for the approved indications for use. The FDA is issuing this letter to ensure you are aware of the manufacturer's recall notice and recommended actions," it added.

The US drug regulator further added that MitraClip was first approved in 2013 to reduce MR in selected patients whose significant symptomatic MR and heart failure symptoms result from abnormalities of the mitral valve (commonly known as primary or degenerative MR); and whose risks for mitral valve surgery are prohibitive.

In 2019, a new indication for the device was approved to include 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. MitraClip has been the only percutaneous (implanted through the skin without open surgery) repair device approved in the United States to treat patients with MR, it said during the time. Pharmabiz