Voluntary recall of Medtronic 23mm Engager™ Transcatheter Aortic Bioprosthesis

Medtronic 3F Therapeutics, Inc would like to inform healthcare professionals of a voluntary recall of Medtronic 23mm Engager™ Transcatheter Aortic Bioprosthesis. A review of the 2-year follow-up data of Engager European Pivotal Trial has shown that 16 of 32 subjects implanted with a 23mm device have a mean gradient of ≥20 mmHg at some point after the implant (average mean gradient at 2-year follow up: 22.0 ± 7.5 mmHg). Gradient is a measure of the resistance to flow through the valve. A mean gradient of 20-40 mmHg is associated with mild stenosis (narrowing of the valve) per the Valve Academic Research Consortium (VARC) -2 guideline. As part of patient management, healthcare professionals are recommended to conduct transthoracic echo in symptomatic patients implanted with the device to assess valve hemodynamics . 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.