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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 medical device safety alert concerning its zenith alpha thoracic endovascular graft (catalogue identifier: all zta-devices). the manufacturer has become aware that the zenith alpha thoracic endovascular graft has been used to treat patients with thoracic aortic dissections. as per instructions for use (ifu), the graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair, including: iliac/femoral anatomy that is suitable for access with the required introduction systems; nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic aneurysm or ulcer: with a length of at least 20 mm, and with a diameter measured outer-wall-to-outer-wall of no greater than 42 mm and no less than 20 mm. to emphasize best practices, the manufacturer would like to reiterate that the graft and ancillary components should be used as specified in the ifu. the ifu section 4.2 “patient selection, treatment and follow up” states that the safety and effectiveness of the zenith alpha thoracic endovascular graft and ancillary components have not been evaluated in the patient populations for dissection. users are also advised to refer to ifu section 5 for potential adverse events associated with either zenith alpha thoracic endovascular graft or the implantation procedure that may occur and/or require intervention. according to the manufacturer, no devices are needed to be returned and patients already treated for a dissection should receive standard follow up procedures. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 august 2018.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: William Cook Europe Zenith Alpha Thoracic Endovascular Graft
  • Manufacturer