Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Medtronic, Inc., has issued a medical device safety alert concerning its EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System [All Models, All Lots] [HKMD No.: 190160]
According to the manufacturer, it is writing to inform an update to the Instructions for Use (IFU) for the EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (herein referred to as EverFlex Entrust). This update provides a validated manual deployment workaround method to help mitigate potential harms related to the low risk of partial stent deployment.
Potential major harms associated with partial deployment include embolism, occlusion/ischemia, vessel perforation, rupture, blood loss, and secondary intervention such as an additional endovascular procedure or surgical conversion. Higher friction forces may occur in longer stent lengths and it is observed that the rate of partial stent deployment is higher for longer stent lengths, such as the 150mm length stent.
The manufacturer has completed validation testing for the manual deployment workaround method update being added to the EverFlex Entrust IFU. These instructions should only be followed in the event a partial stent deployment occurs. The manufacturer is taking this action to reduce the severity of potential patient harms. The steps are intended to reduce or avoid the need for secondary or surgical intervention in the event of partial stent deployment.
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Jul 2022