Association of Ovation iX Abdominal Stent Graft Systems with polymer leak during implantations

A Dear Healthcare Professional Letter has been issued by Somnotec (S) Pte Ltd to inform healthcare professionals of the safety updates regarding polymer leaks with Ovation iX Aortic Body Stent Graft during implantation. This impacts all lot/serial numbers of Ovation iX Abdominal Stent Graft Systems. Currently, the polymer leak rate is 0.86% over the lifetime of distribution of the device. Clinical events related to polymer leaks may be systemic and/or aneurysm related. Healthcare professionals are advised to review the treatment recommendations in the letter and to disseminate it to relevant staff members to ensure awareness and immediate patient treatment in the event of a polymer leak during implantation. 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.