Events

Rappel de Zenith Alpha Thoracic Endovascular Graft

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par William A Cook Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00101-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-02-10
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00101-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Cook medical is informing their customers that additional warnings and precautions are being implemented in the instructions for use (ifu) for the zenith alpha thoracic endovascular graft. the updates to the ifu are being made to emphasise best practices in response to a few recent findings of distal type i endoleak, migration and aneurysm growth during on-going longer-term follow-up of patients enrolled in the multi-national clinical investigation of the device.
  • Action
    Cook Medical is notifying surgeons and hospitals of the updated information in the package insert. Surgeons are advised that patients already implanted with the device should receive additional surveillance and treatment where required. Further information can be found on the TGA web site at https://www.tga.gov.au/alert/zenith-alpha-thoracic-endovascular-graft. This action has been closed-out on 15/02/2017.

Device

Zenith Alpha Thoracic Endovascular Graft

Manufacturer

William A Cook Australia Pty Ltd