Events

Alerta De Seguridad para COSTAR - Coronary Stent with Elution of Paclitaxel. Registration in Anvisa n ° 80224390132. Risk Class IV - Maximum Risk.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por CONOR MEDSYSTEMS IRELAND LTDA.

¿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
    872
  • Fecha
    2007-06-12
  • 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
    According to information from Biotronik Ltda, the study carried out does not show any deficiencies regarding the safety of the device. However, based on the results of the research, the manufacturer (Costar Ltda) decided to stop the commercial sale of the product and to remove all COSTAR stent units from the market. As a distributor of Conor Ltda in Brazil, Biotronik Ltda is attending this corrective action in the national market and informs that it has already contacted its customers. Anvisa's Technovigilance Unit is monitoring this case.
  • Causa
    A recent study by the manufacturer (conor medsystem ireland, ltda - ireland) with the costar stent did not prove the non-inferiority of the same in relation to the stent taxus express 2, also used for elution of paclitaxel and manufactured by the same company. in view of the results of the study, the manufacturer decided to withdraw the costar stent from the market.
  • Acción
    The company Biotronik Ltda (holder of the registration of the COSTAR Stent in Brazil) coordinates the withdrawal action of the product at the national level and informs that it has already contacted its clients, through informative letters, requesting the immediate interruption of the use of said product .

Device

COSTAR - Coronary Stent with Elution of Paclitaxel. Registration in Anvisa n ° 80224390132. Risk ...

Manufacturer

CONOR MEDSYSTEMS IRELAND LTDA
  • Source
    ANVSANVISA