Events

Rappel de Cook Zenith Alpha™ Thoracic Endovascular Graft

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par William Cook Europe ApS.

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
    18087
  • Date de mise en oeuvre de l'événement
    2015-02-12
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Cause
    The instructions for use supplied with the device are being updated in response to 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. to date, no similar events have been reported from markets in which the device is commercially available. these findings from the clinical investigation were found to be associated with thoracic aneurysms (not ulcers) treated with a single proximal component that resulted in a short distal seal length (i.E., less than 20 mm) and likely inadequate (i.E., less than 10%) distal oversizing for the device.
  • Action
    Instructions for use to be updated

Device

Cook Zenith Alpha™ Thoracic Endovascular Graft

Manufacturer

William Cook Europe ApS