Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Lotus Edge Valve System [UPN: H749LVS230, H749LVS250, H749LVS270, H749LVSCL230, H749LVSCL250, H749LVSCL270].
The manufacturer is implementing a voluntary Field Safety Corrective Action for the recently launched LOTUS Edge Valve System to remove all units from the field.
There have been seven reports where the valve could not be fully locked and released. In six cases, the valve was retrieved and removed, resulting in procedure prolongation. In one case the valve was positioned in the descending aorta. In all seven cases, the patient was successfully treated with a new valve.
The manufacturer has not received any reports of other serious adverse events associated with this failure mode. However, potential complications could include stroke and/or vessel trauma.
According to the manufacturer, there is no safety issue for patients who previously received a LOTUS Edge valve since the issue only occurs during the implant procedure and does not impact the performance of the implanted valve.
Product recall is on-going.
According to the local supplier, the affected products are NOT distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 November 2016