Events

Alerte De Sécurité sur Axxess Drug Eluting Coronary Bifurcation Stent System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Biosensors International.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-12-13
  • Date de publication de l'événement
    2013-12-13
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131213.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biosensors International Axxess Drug Eluting Coronary Bifurcation Stent System
  • Manufacturer
    Biosensors International

Manufacturer

Biosensors International