Venovo™ Venous Stent System 9F: Potential for proximal end of stent not to expand immediately upon deployment for specific product lots

A Dear Healthcare Professional Letter has been issued by Bard Singapore Pte Ltd to inform healthcare professionals that the proximal end of the stent of specific lots of the Venovo™ Venous Stent System 9F may not immediately expand upon deployment. In cases in which this occurs, and the stent is allowed sufficient time to self-expand, there is no incremental risk of harm. However, over-manipulation or forcing the catheter delivery system in attempts to assist the stent’s expansion could potentially prolong the procedure, damage or deform the stent or cause potential vascular injury, hemodynamic disruption affecting the blood flow and/or a thrombotic event. Healthcare professionals are advised to continue the use of the affected products and allow sufficient time for the stent to self-expand, without over-manipulation of the catheter delivery system. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

10 Feb 2021

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.moh.gov.sg/hpp/, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.