Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its VICI and VICI RDS Venous Stent Systems [All Lots/Batches].
The manufacturer is initiating a global removal of VICI and VICI RDS Venous Stent Systems. It has received reports of stent migration after implantation. Some of which required endovascular intervention to secure or retrieve the stent. In more severe cases, the stent has embolised to the heart, resulting in the need for surgery.
Patients who have had VICI stent are recommended by the manufacturer to continue with their follow-ups. Meanwhile users should identify, quarantine and return the affected products.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 April 2021