Vici SDS (venous stents)

2021: Withdrawal of defective stents that shift after implantation

At the end of May 2021, Boston Scientific initiated the recall of its Vici SDS and Vici RDS venous stent systems. The recall received a Grade I designation, that is, it is associated with problems potentially threatening the life and health of patients.

Vici SDS and Vici RDS venous stent systems are designed to treat obstruction and occlusion in narrowed or occluded veins. According to a regulatory notice, the company recalled the stent systems after reports that the devices could move from the place of implantation.

If the stent shifts from its original location, another surgery or catheterization procedure may be required to remove it, which increases the risk to the patient. Risks associated with this problem include possible damage to blood vessels, heart walls or other organs, while migration of the stent to the heart can cause life-threatening injuries.

Boston Scientific recalls defective Vici SDS and Vici RDS stents that shift after implantation

At the end of May, the company received 17 complaints and reports of injuries related to the removal of stents. However, no fatalities were reported.

Boston Scientific initiated the recall of 31,798 devices that were available on the US market from August 21, 2018 to April 9, 2021.

In an urgent notification of the recall of the medical device, customers were asked to immediately stop using these stents, remove all devices from the inventory and secure them, as well as arrange their return to Boston Scientific to receive compensation.

Boston Scientific voluntarily initiated the recall of all unimplanted Vici and Vici RDS venous stent systems due to reports of stent displacement after implantation, the company said in a statement. - Feedback was carried out at the request of regulators. Although the incidence of stent displacement after implantation was extremely low at 0.08%, we decided to recall the devices, maintaining the company's high safety standards.[1]

Notes