Events

Notificaciones De Seguridad De Campo acerca de Pipeline Embolization Device

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 Covidien.

¿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
    2012-05-12
  • Fecha de publicación del evento
    2013-01-17
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2013/01/17/vazno-obavestenje-o-medicinskom-sredstvu-pipeline-embolization-device-sredstvo-za-embolizaciju-cerebralnih-aneurizmi/
  • 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
    Since commercialization of the pipeline embolization device (ped), covidien has conducted postmarket surveillance of the clinical use of our ped system. our current postmarket data continues to demonstrate morbidity and mortality rates in alignment with those noted in the pufs (pipeline for failed aneurysm) trial that was clinical basis for us commerical approval of the device. rates of major neurologic complications or death in the pufs clinical trial were 5.6% (2.8% for morbidity and 2.8% for mortality). with over 15,000 ped devices implanted to date, the rate of overall morbidity and mortality are 2.6% and 1.6% respectively.

Device

Pipeline Embolization Device

Manufacturer

Covidien
  • 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
    ALIMSA