Events

Notificaciones De Seguridad De Campo acerca de IntraStent Unmounted Balloon Expandable Stent

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Ev3.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2008(01)
  • Fecha
    2008-01-24
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/intrastent-unmounted-balloon-expandable-stent&id=9699f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
  • Causa
    The manufacturer, ev3, has advised the irish medicines board (imb) of a recall of specific lots of the intrastent unmounted balloon expandable stent.    the manufacturer has confirmed that the following affected lot / serial numbers have been supplied to the irish market:    4206244, 1688027, 1979986, 3003378.
  • Acción
    Ensure that the relevant personnel in your organisation are made aware of this recall. Determine if you have purchased the affected lots of this product. Quarantine and return any unused affected product to ev3, United Kingdom office (see address below). Advise the IMB if you have the affected product.

Device

IntraStent Unmounted Balloon Expandable Stent
  • Modelo / Serial
    4206244, 1688027, 1979986, 3003378
  • Descripción del producto
    IntraStent Unmounted Balloon Expandable Stent
  • Manufacturer
    Ev3

Manufacturer

Ev3
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HPRA