Important update on Nellix® EndoVascular Anerysm Sealing System following complaints of caudal migration of the stent-graft-Endobag

Qualtech Consulting Corporation Pte. Ltd. would like to inform healthcare professionals of an update to the use of the Nellix® EndoVascular Aneurysm Sealing System, which highlights the importance of both anatomical and procedural criteria in determining the risk of experiencing a Nellix-related complication. There have been complaints on caudal migration of the stent-graft-EndoBag system since the device’s introduction. This hazard of migration may lead to abdominal aortic aneurysm sac pressurisation. The Information For Use (IFU) will be updated to include the procedural criteria impacting Nellix Success. Healthcare professionals are advised on the importance of patient-tailored surveillance recommendations, which include regular follow-up of patients who would now be considered at-risk of a Nellix-related complication according to the refined anatomical and/or procedural criteria in the IFU. Please refer to the letter for details.
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

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

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.