Events

Alerta De Seguridad para 1) NIRoyal Coronary Stents; Premounted Coronary Stent Systems: (2) NIRoyal Elite, (3) NIRoyal Advance, (4) NIRoyal Elite Monorail, (5) NIRoyal Elite Over-the-Wire

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Boston Scientific Ltd.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    681
  • Fecha
    2002-08-29
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The uk medical devices agency (mda) has issued a product alert after the manufacturer has received 9 alerts of radial stent fractures, coronary endoprosthesis systems. the fractures occurred between 3 weeks and 9 months after implantation. in 8 cases, the patients presented with recurrent angina. the manufacturer issued a product information alert to users dated june 2002.
  • Acción
    MDA recommends the following to health professionals: (1) be aware of the possibility of a radial fracture if patients implanted with the above stent grafts present with angina. No change to clinical management is indicated for asymptomatic patients. (2) report all suspected or known cases of radial fracture in the endoprostheses to the manufacturer, Inquiries to the manufacturer should be addressed to the local representative, or directly to Brian Howlett or Peter Dekkers, Boston Scientific Ltd, by mail at the address given below, by telephone (0172) 779-7608, or by fax at (0172) 786 5862.

Device

1) NIRoyal Coronary Stents; Premounted Coronary Stent Systems: (2) NIRoyal Elite, (3) NIRoyal Adv...

Manufacturer

Boston Scientific Ltd
  • Source
    ANVSANVISA