Events

Rappel de Multiple Zenith Alpha Thoracic Endovascular Graft Products

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-2017-RN-00419-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-03-29
  • 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-2017-RN-00419-1
  • 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
    The instructions for use (ifu) for the zenith alpha thoracic endovascular graft have been updated. these updates are of key importance when using the device to treat blunt thoracic aortic injury (btai), which is now covered under the newly approved indication for isolated lesions of the descending thoracic aorta. there have been five reports of graft thrombosis/occlusion during global commercial use of the device, each following treatment for btai. one case resulted in patient death, and three cases resulted in reintervention. patients already treated for btai should be followed in accordance with the current ifu, since follow-up has not been amended.
  • Action
    Cook Medical is requesting surgeons refer to the new version of the Instructions for Use (IFU) for the Zenith Alpha Thoracic Endovascular Graft in particular to the key updates regarding the use of the device to treat blunt thoracic aortic injury (BTAI), which is now covered under the newly approved indication for isolated lesions of the descending thoracic aorta. Surgeons are advised that patients already treated for BTAI should be followed in accordance with the current IFU, since follow-up has not been amended. (Please note that this recall is for information purposes. No devices need to be returned).

Device

Multiple Zenith Alpha Thoracic Endovascular Graft Products
  • Modèle / numéro de série
    Multiple Zenith Alpha Thoracic Endovascular Graft ProductsAll products that start with the following Catalogue Numbers:Proximal Tapered Component; ZTA-PT-Distal Component; ZTA-D-Distal Extension; ZTA-DE-Proximal Component; ZTA-P-ARTG Numbers: 222505, 222526, 222533, 222525
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd