Medical device manufacturer, Stryer, has issued a medical device safety alert concerning its Trevo XP ProVue Retriever. The details of the affected products distributed in Hong Kong are identified as follows: Affected products [Catalogue Numbers and Lot Numbers]:
The manufacturer has observed an increase in complaints involving fractures of the core wires of the affected products for certain lots manufactured between the time period of 22 Jul 2019 to 9 Sep 2019 resulting in stent retriever separation from the core wire during use.
According to the manufacturer, the complaint rate for fracture in 2020 was noted to be higher than historical data for the identified lots manufactured during the above mentioned time period. A Health Hazard Evaluation was completed to assess the potential hazardous situation of retriever core wire fractures during use. It was determined that when the core wire fracture occurs, the stent retriever can be left behind in the vasculature.
For potential patients, in the event of the device fracture during use, there is a risk of serious injury or death. For patients previously treated with the impacted device, the potential risks is none.
Users are required to take the following actions:
Product recall for removal is on-going.
According to the local supplier, the affected devices have been distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 September 2020