CDSCO issues Medical Device Alert for Abbott MitraClip Device
New Delhi: Suspecting the risk of potential clip lock malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott, the Central Drugs Standard Control Organization (CDSCO) has issued a Medical Device Alert for MitraClip G4 Clip Delivery System and MitraClip NTR/XTR Clip Delivery System which are used as heart valve repair device, intended to treat mitral regurgitation.
This medical device alert follows the release of a medical device safety notice by Abbott subsidiary St. Jude Medical India, which said that the company had noticed an increase in complaints concerning clip locking issues with the MitraClipTM Delivery System.
The MitraClip Clip Delivery System is a heart valve repair device that is intended to treat mitral regurgitation. Mitral valve regurgitation is a type of heart valve disease in which the valve between the left heart chambers doesn't close completely, allowing blood to leak backward across the valve.
Regarding the risk the Medical Device Alert highlighted the increased rate of reports for clips failing to “Establish Final Arm Angle” (EFAA) and for events of “Clip Opening While Locked” (COWL).
Explaining about the “Establish Final Arm Angle” (EFAA) the alert stated, " EFAA is a procedural step where the user intentionally attempts to open a locked Clip to verify that the locking mechanism is engaged. EFAA steps occur during device preparation and prior to Clip deployment. An EFAA failure occurs if the Clip opens during this verification step"
Furthermore, the alert mentioned COWL, which stands for Clip Opening While Locked. COWL describes when the Clip Arm angle increases post-deployment. In these cases, users observe a slippage 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.
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In addition, the alert added, "When the clip is locked, the locking mechanism is designed to more fully engage as the Grippers push down on the clip Arms. The constant force applied by the Grippers secures the leaflets within the clip. During a COWL event, the lock slips as the Clip Arms open by a given degree. In any case where significant residual MR is observed after Clip deployment, a second clip should be considered and implanted in accordance with the IFU "
Additionally, the alert addressed Who May Be Affected by saying,
a. Any person with mitral regurgitation who has to be treated with the use of MitraClip™ G4 Clip Delivery System and MitraClip™ NTR/XTR Clip Delivery System
b. Health care providers who treat people with mitral regurgitation using the affected MitraClip™ G4 Clip Delivery System and MitraClip™ NTR/XTR Clip Delivery System
However, CDSCO stated that it had not heard from the market regarding any complaints regarding this matter.
