Boston Scientific has sent a letter to its customers notifying them that it is implementing a “voluntary Field Safety Corrective Action (FSCA)” for its Lotus transcatheter aortic valve implantation (TAVI) system. In the letter, the company reports that action is to remove units from the field that were manufactured prior to a component-related change made in March 2016. The company adds there is no additional safety issue for patients who previously received a Lotus implant because the issue “only involves the delivery system and is not related to the performance of the implanted valve”.
The action is related to release mandrel breaks—the release mandrel is a component of the delivery system that is connected to the release pin that facilitates release of the valve from the delivery system. According to Boston Scientific, there has been a number of release mandrel breaks reported for Lotus systems manufactured prior to the component change (March 2016). It says that the most common outcome was resheathing and removing the device, resulting in procedural prolongation. “However, the most severe outcome was catastrophic vessel trauma associated with patient death, which was reported in three cases,” the company adds. Boston Scientific says it has not received any reports of release mandrel breaks for units built after the component change in March 2016. The company is now taking action to remove all units from the field that were manufactured prior to this change.
In the letter, Boston Scientific instructs customers to immediately discontinue use of all affected products and remove all of the affected units from their inventory, regardless of where these units are stored in their facility. Segregate the units in a secure place, pending return to Boston Scientific. They also ask customers to “please pass this notice to any health professional of your organisation that need to be aware and to any organisation where the potentially affected devices have been transferred (If appropriate).”
Boston Scientific states that products manufactured after the implementation of the change in March 2016 are not impacted and, therefore, operators can continue to treat patients with those units.