Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Lotus Valve System [UPN: H749LTV230, H749LTV250, H749LTV270, H749LTVR3CL230, H749LTVR3CL250, H749LTVR3CL270].
The manufacturer is implementing a voluntary FSCA for the Lotus Valve System to remove units from the field that were manufactured prior to a component related change made in March 2016. Products manufactured after the implementation of this change are not impacted. There is no additional safety issue for patients who previously received a Lotus implant since the issue only involves the delivery system and is not related to the performance of the implanted valve.
According to the manufacturer, this action is related to a release mandrel breaks. The release mandrel is a component of the delivery system that is connected to the release pin which facilitates release of the valve from the delivery system. The manufacturer has not received any reports of release mandrel breaks for units built after the component change in March 2016.
There was a number of release mandrel breaks reported for product manufactured prior to the component change. The most common outcome was resheating and removing the device without difficulty, resulting in procedural prolongation. However, the most severe outcome was catastrophic vessel trauma associated with patient death, which was reported in three cases.
The manufacturer is now taking action to remove all units from the field that were manufactured prior to the change. The affected users are instructed to quarantine the affected products.
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 4 August 2016