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Health Sciences Authority
Dear Healthcare Professional Letters

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

Audiences

Healthcare professional

Industry member

Product type

Medical devices

28 February 2024

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

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.

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.

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