Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Medtronic SA.

¿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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 036 08 16 001
  • Fecha de inicio del evento
    2016-08-31
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9917
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01015-1
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    A review was completed of all evolut r product complaints that indicated vascular trauma during use of the enveo r delivery catheter system (dcs) from the date of the first commercial evolut r product (august 2014) through may 2016. this review identified a total of 39 events (occurrence rate of 0,136%), each of which reported insertion, advancement, or positioning difficulties associated with complicated patient anatomy (tortuosity, calcification, bicuspid valve, or existing bioprosthesis). the cause of these vascular trauma complaints has been determined to be related to the difficulties maneuvering the enveo dcs in tortuous or highly calcified patient anatomy, which resulted in physicians manipulating or applying extra force to the dcs, leading to vascular trauma in a small sub-set of attempted evolut r implants. there is no indication of any non-conformance or failure of the dcs to meet requirements.

Device

EnVeo R Delivery Catheter System
  • Modelo / Serial
    Model number: ENVEOR-L ……………………… TGA update code : Models: ENVEOR-L-C
  • Descripción del producto
    Aortic transcatheter heart valve bioprosthesis
  • Manufacturer
    Medtronic SA

Manufacturer

Medtronic SA
  • 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.
  • Representante del fabricante
    Medtronic Saudi Arabia
  • Source
    SFDA