Important Safety Alerts

Medical device manufacturer, Terumo Corporation, has issued a medical device safety alert concerning its Misago Peripheral Self-Expanding Stent System. The affected devices are identified as follows:-

• Product Codes: All Misago products starting with SF*F or SX-V
• Lot Number: All products on the market within the labeled expiration period (Manufactured from September-2013 through August-2016)

During the inspection process, the manufacturer identified a low occurrence rate of two types of non-conformances in comparison to the specifications as described in the regulatory applications:

1. Reduced diameter at one, or both ends of the stent due to incomplete self-expansion after release from the delivery catheter; and
2. Deformation of the stent strut shape due to the compression forces that are applied to compact, and mount the stent to the delivery catheter.

According to the manufacturer, the body of clinical evidence as related to Misago stents supports that clinical performance is not affected in that there are no new or additional complications, or adverse health consequences. The Health Hazard Evaluation concluded that the nonconformity in the dimension (reduced diameter rat the ends of the stent), or in the stent shape (a bend or inconsistent alignment of the stent struts), will have no impact to safety, or effectiveness, of the product. Therefore, there is no additional risk of serious health harm posed by these nonconforming products. The manufacturer has not received customer complaints, or adverse events, related to incomplete stent expansion, stent deployment failure, insufficient diameter, or stent deformation.

Product recall is ongoing.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 12 August 2016