HeartMate 3™ LVAS Kits & HeartMate 3 Outflow Grafts, HeartMate II™ LVAS Kits & HeartMate II Outflow Grafts – Extrinsic Outflow Graft Obstruction (EOGO)

A Dear Healthcare Professional Letter has been issued by Abbott Medical (Singapore) to inform healthcare professionals of a planned update to the Instructions For Use (IFU) due to an observed outflow graft deformation known as “Extrinsic Outflow Graft Obstruction” (EOGO) associated with the HeartMate 3™ Left Ventricular Assist System (LVAS) and HeartMate II™ LVAS. EOGO is caused by the accumulation of biological materials (acellular biodebris) between the HeartMate Outflow Graft and the Outflow Graft Bend relief or a non-HeartMate component. Significant EOGO will manifest clinically as a persistent low flow alarm under certain circumstances in some patients and may impair the ability of the HeartMate LVAS to provide adequate haemodynamic support. If untreated, persistent low flow may result in hemodynamic compromise, the need for surgical intervention, possible pump replacement, and risk of death. Healthcare professionals are advised to pay attention to low flow alarms as this is the first symptom of significant outflow obstruction and to follow a suggested diagnostic algorithm to determine if significant EOGO is present and contributing to observed low flow alarms that are not able to be resolved. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

4 Mar 2024

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.