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Health Sciences Authority
Dear Healthcare Professional Letters

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

Audiences

Healthcare professional

Product type

Medical devices

5 December 2018

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

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.

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 (opens in new tab) 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.