Update to medical device correction due to outflow graft twisting in Thoratec® HeartMate III™ LVAS Implant Kit

Transmedic Pte Ltd would like to provide additional information to the previous letter issued on 2 May 2018 on Outflow Graft twist occlusions in the Thoratec Heartmate III™ LVAS Implant Kit. The information includes further clarifications on the origin of the Outflow Graft twist, the definition of persistent low flow alarm, and additional recommendations for patient management. Additional recommendations for patient management include procedural steps on attaching the Outflow Graft and follow up of implanted patients with surveillance echo exam at specified intervals. The proposed warnings and additional caution statements for the attachment of the Outflow Graft to the Pump will be incorporated into the Instructions for Use upon regulatory approval. 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.