Events

Alerta De Seguridad para Zenith Alpha Thoracic Endovascular Graft

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por William Cook Europe.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-02-06
  • Fecha de publicación del evento
    2015-02-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150206.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: William Cook Europe Zenith Alpha Thoracic Endovascular Graft
  • Manufacturer
    William Cook Europe

Manufacturer

William Cook Europe