Non-functionality of MitraClip XTR Clips due to excessive force applied during implantation

Abbott Laboratories Singapore Pte Ltd would like to update healthcare professionals on confirmed reports of MitraClip XTR Clips unexpectedly opening and becoming non-functional due to unintended excessive force applied to the Clip during implantation. Once the Clip becomes non-functional, the inability to close and remove the device can lead to surgery or additional intervention. The Instructions for Use has been updated to include information that explains the changes to the steps for use and emphasizes the importance of preventing unintended excessive force to the Clip.  Healthcare professionals are advised to follow the revised instructions provided in the letter to ensure consistency of use. 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.