Events

Alerte De Sécurité sur Zenith Alpha Thoracic Endovascular Graft

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

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
    2015-02-06
  • Date de publication de l'événement
    2015-02-06
  • 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_20150206.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: william cook europe zenith alpha thoracic endovascular graft medical device manufacturer, william cook europe, has issued a field safety notice concerning zenith alpha thoracic endovascular graft [reference number: 2015fa0001]. the manufacturer identified a few cases 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. these findings were found to be associated with thoracic aneurysms 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. the manufacturer has revised the instructions for use to include additional warnings and precautions on the above issues. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 february 2015.

Device

Zenith Alpha Thoracic Endovascular Graft
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: William Cook Europe Zenith Alpha Thoracic Endovascular Graft
  • Manufacturer
    William Cook Europe

Manufacturer

William Cook Europe