Important Safety Alerts

Medical device manufacturer, Biosensors International, has issued a field safety notice concerning 4.0 x 9mm model of Axxess Drug Eluting Coronary Bifurcation Stent System (AXBF-4009) (Lot numbers: W13090159 and W13080132).

Several cases with deployment difficulty have been reported to Biosensors International Group to date, concerning the affected device. Physicians in these cases found it either difficult or impossible to pull back the deployment actuator. This could potentially lead to a sub-optimal deployment. In most cases, the stent was successfully deployed, resulting in a positive clinical patient outcome. In the remaining cases, deployment was aborted and patients were administered alternative treatment, with positive patient outcomes. There have been no reports of adverse patient events.

The manufacturer has the following recommendations:

• For all successfully implanted devices, no action is necessary and patients should continue to be managed in accordance with standard patient management protocol.
• Quarantine and return any remaining stocks of affected product.

According to the local supplier, the affected products were not distributed in Hong Kong.

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 13 December 2013