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Health Sciences Authority
Dear Healthcare Professional Letters

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

Audiences

Healthcare professional

Industry member

Product type

Medical devices

3 February 2021

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

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.

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.

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