Update to the Instructions for Use for Zenith Alpha™ Thoracic Endovascular Graft

Cook South East Asia Pte Ltd would like to inform healthcare professionals of an update to the instruction for use (IFU) for the Zenith Alpha™ Thoracic Endovascular Graft. This IFU update follows recent clinical findings of distal Type I endoleak, migration and aneurysm growth during on-going longer-term follow-up of patients. The findings were found to be associated with thoracic aneurysms treated with a single proximal component that resulted in a short distal seal length and likely inadequate distal oversizing for the device. Healthcare professionals are recommended to provide additional surveillance and necessary treatment to patients who have been treated with the device, and to adhere to the additional warnings and precautions in the IFU prior to use of the device in future patients. 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.