Events

Notificaciones De Seguridad De Campo acerca de SMART Vascular Stent System

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 Cashel.

¿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
    2017-02-16
  • Fecha de publicación del evento
    2017-10-03
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2017/03/10/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-smart-vascular-stent-system/
  • 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
    Following recent complaints and a follow-up investigation, cordis found that the s.M.A.R.T. 5x200mm and 6x200mm was linked to a higher incidence of incidents resulting from difficulty in placing these stents compared to other sizes. the most commonly reported difficulty with the placement of a stent is the inability to place the stent, which led to delays during the procedure due to the preparation of a replacement medical device. however, partial stent placement may cause ischemia or internal bleeding which would require additional intervention. since launching these products in 2013, a total of 3 injuries have been reported worldwide for complaints of stent placement issues (bleeding at the stent insertion site in one case, and causing a thrombus twice) and neither is believed to be in connection with this medical device. however, the causal connection cannot be completely disconnected at this time.

Device

SMART Vascular Stent System
  • Modelo / Serial
    numbers SF05200MV; SF05200SV; SF06200MV; SF06200SV lots 34469-39974
  • Manufacturer
    Cordis Cashel

Manufacturer

Cordis Cashel