Events

Notificaciones De Seguridad De Campo acerca de Cordis OptEase Retrievable Vena Cava Filter

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por Cordis Europa N.V..

¿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
  • Fecha
    2013-03-04
  • Fecha de publicación del evento
    2013-04-22
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2013/04/22/vazno-obavestenje-o-medicinskom-sredstvu-cordis-optease-retrievable-vena-cava-filter-filter-vena-cava/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    Through continuous post-market safety surveillance, cordis has identified a series of recent events in which the optease® retrievable vena cava filter was implanted in the opposite orientation to that specified in the product instructions for use (ifu). a total of fifteen (15) events have been reported since 2006, including four events received in the last six (6) months.Based on cordis’ investigation, cordis has learned the optease® retrievable vena cava filter was placed with the retrieval hook towards the superior vena cava, inadvertently in some cases, or by the implanting physician’s decision in others. in at least four (4) cases, the filter migrated to the right heart; open heart surgery was needed in two cases. no deaths related to this issue have been reported.

Device

Cordis OptEase Retrievable Vena Cava Filter

Manufacturer

Cordis Europa N.V.