Events

Notificaciones De Seguridad De Campo acerca de 200 mm sinus-SuperFlex-635 self-expanding nitinol stent system

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por optimed Medizinische Instrumente GmbH.

¿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
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    This corrective action is based on the investigation of field complaints which indicates an increased number of deployment issues of sinus superflex-635 stents with 200 mm length. non-deployments were reported as well partial deployments of the stent. partially deployed stents may require an additional intervention by a doctor due to stent elongation or fracture. this recall does not affect any patient with an implanted stent of this length since this problem may only occur during the implantation of the device. .

Device

200 mm sinus-SuperFlex-635 self-expanding nitinol stent system
  • Modelo / Serial
    8606-6200/ sinus-SuperFlex-635, Stent system, 6x200 mm, 6F/ 75 cm, .035i, application device 8606-7200/ sinus-SuperFlex-635, Stent system, 6x200 mm, 6F/ 120 cm, .035i, application device 8607-6200/ sinus-SuperFlex-635, Stent system, 7x200 mm, 6F/ 75 cm, .035i, application device 8607-7200/ sinus-SuperFlex-635, Stentsystem, 7x200 mm, 6F/ 120 cm, .035i, application device
  • Manufacturer
    optimed Medizinische Instrumente GmbH

Manufacturer

optimed Medizinische Instrumente GmbH