FDA MedWatch – VICI VENOUS STENT System and VICI RDS VENOUS STENT System by Boston Scientific Corporation:

TOPIC: VICI VENOUS STENT System and VICI RDS VENOUS STENT System by Boston Scientific Corporation: Class I Recall – Due to Potential of Stent Migration

AUDIENCE: Patient, Health Professional, Risk Manager

ISSUE: Boston Scientific is recalling the VICI SDS and RDS VENOUS STENT Systems after reports indicate that the stents may migrate or move from where they are initially implanted.

A migrated stent may require another surgery or catheter procedure to retrieve it, which increases risks to the patient, including possible damage to the blood vessel, heart walls or other organs. If the stent migrates to the heart, it could cause life-threatening injury.

There have been 17 complaints and reported injuries related to this issue. No deaths have been reported.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: The VICI SDS and VICI RDS VENOUS STENT Systems are intended for the treatment of obstructions and occlusions in the narrowed or blocked venous veins.

RECOMMENDATIONS: On April 12, 2021, Boston Scientific Corporation sent an Urgent Medical Device Recall Notification to customers asking them to:

• Immediately discontinue use of the device
• Remove all affected units from inventory and secure them
• Complete the company’s Verification Form to acknowledge receipt and report products that will be returned
• Package affected products for shipping and contact the local Boston Scientific representative to arrange for their return

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.