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Health Sciences Authority
Dear Healthcare Professional Letters

Advisory on Clip locking integrity issue with Abbott MitraClip™ G4 System and Abbott Vascular TriClip™ System

Audiences

Healthcare professional

Industry member

Product type

Medical devices

16 September 2022

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by Abbott Medical (Singapore) Pte Ltd to inform healthcare professionals of a potential issue with the clip locking mechanism of the Abbott MitraClip™ G4 System and Abbott Vascular TriClip™ System. There has been an increased rate of reports of Clip locking malfunctions, including the failure to “Establish Final Arm Angle (EFAA)” during verification of the locking mechanism and events of “Clip Opening While Locked” (COWL), where users observe a slippage in the lock resulting in an arm angle greater than 10 degrees from the angle observed at deployment. Abbott has identified a contributing cause of EFAA failure/COWL events as a change in the material properties of one of the Clip locking components and is working on producing new lots with updated manufacturing processing and raw material to mitigate EFAA failure/COWL events. Healthcare professionals are advised to consider the need for a second Clip in cases where significant residual mitral regurgitation or tricuspid regurgitation is observed after Clip deployment. They are also advised to continue to follow the procedures in the Instructions for Use to aid in the optimal functioning of the Clip locking mechanism to reduce the occurrence of EFAA failure and COWL events. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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