Medical device correction due to outflow graft twisting in Thoratec® Heartmate III™ LVAS Implant Kit

Transmedic Pte Ltd would like to inform healthcare professionals that Abbott has received reports of outflow graft twist occlusions in the Thoratec^® Heartmate III^™ Left Ventricular Assist System (LVAS) Implant Kit. Heartmate III^™ outflow graft twists can result in serious adverse events such as hemodynamic compromise, thrombus, and death. Patients whose devices experience these outflow graft occlusions will present a persistent low flow alarm which may occur at any point beyond implant. Postoperative twisting and occlusion of the outflow graft may result in the need for surgical intervention following the original implant procedure. Healthcare professionals are advised to refer to the letter on managing patients that will be implanted or already implanted with the Heartmate III^™ device. 

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.