Events

Alerta De Seguridad para EVEROLIMUS ELUTING CORONARY STENT. ANVISA Register: 80146501423. Model XIENCE V. Batch Affected: 8040841.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Aboott Laboratórios do Brasil 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
    962
  • Fecha
    2009-04-08
  • 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 Abbott Ltda, the problem is noticeable during the preparation of the material - hence, therefore, of the stent implantation in the patient - and does not affect the stent itself. The reason for the recall was the receipt of three case reports by Abbott regarding the problem in the distal rod of the product. The Technovigilance Unit is following up on this case.
  • Causa
    The balloon of the distal tip of the catheter, responsible for the implantation of the stent, may not inflate until the end. this problem may compromise the implantation of the stent in the patient.
  • Acción
    The holder of the registration of the product in Brazil has already begun the communication to the customers involved and the collection of the affected products in the market. Users are advised to: (1) Check for affected batch products in stock; (2) Collect affected products and segregate them, identifying them properly to avoid misuse; (3) Contact the product registration holder in Brazil.

Device

EVEROLIMUS ELUTING CORONARY STENT. ANVISA Register: 80146501423. Model XIENCE V. Batch Affected: ...

Manufacturer

Aboott Laboratórios do Brasil Ltda.
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA