Events

Safety Alert for Axxess Drug Eluting Coronary Bifurcation Stent System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Biosensors International.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-12-13
  • Event Date Posted
    2013-12-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131213.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: biosensors international axxess drug eluting coronary bifurcation stent system 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.

Device

Axxess Drug Eluting Coronary Bifurcation Stent System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biosensors International Axxess Drug Eluting Coronary Bifurcation Stent System
  • Manufacturer
    Biosensors International

Manufacturer

Biosensors International