Updates to Instructions for Use (IFU) concerning Erosion with the Amplatzer Atrial Septal Occluder (ASO)

St. Jude Medical would like to inform healthcare professionals on the updates to the Instructions for Use (IFU) of the Amplatzer Atrial Septal Occluder (ASO) due to concerns of tissue erosion. In rare instances, the tissue surrounding the Amplatzer ASO can erode and result in life-threatening emergencies that require immediate surgery. The potential risk for erosion has remained constant over time, with worldwide estimated incidence rate of between 0.1% and 0.3%. As a risk mitigation measure , St. Jude Medical has updated the IFU to provide guidance to physicians on the use of the Amplatzer ASO. Healthcare professionals are advised to refer to the Dear Healthcare Professional Letter for more 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.