Updates to Instructions for use of EverFlex™ Self-Expanding Peripheral Stent with Entrust ™ Delivery System to mitigate risk of partial stent deployment

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of an update to the Instructions for Use (IFU) for the EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System. This update provides a validated manual deployment workaround method to help mitigate potential harms related to the low risk of partial stent deployment and to reduce or avoid the need for secondary or surgical intervention in the event of partial stent deployment. No actions are required for patients where EverFlex™ Entrust™ was previously used during a procedure. No product retrievals or disposals are requested by Medtronic and the product can continue to be used in accordance with the updated IFU. Healthcare professionals are advised to follow the instructions for manual deployment workaround method only in the event that a partial stent deployment occurs; in a no deployment situation, the device is to be removed as per the IFU recommendations and disassembly should not be attempted. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

27 Jul 2022

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.