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Public Alert No.024/2021 – Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration

July 8, 2021,

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by the U.S Food and Drug Administration (FDA) that Boston Scientific is recalling the VICI VENOUS STENT System (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, 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.

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

NAFDAC implores healthcare professionals, distributors, importers in possession of the recall medical device to discontinue sale or use and handover remaining stock to the nearest NAFDAC office.

Health professionals and patients are encouraged to report adverse events or quality problems experienced with the use of the products to the nearest NAFDAC office, NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks] or via pharmacovigilance@nafdac.gov.ng or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng or via Med Safety Application available for download on Android and IOS stores.

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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