Alerta De Seguridad para ANASTAFLO SHUNT INTRAVASCULAR. Record number 80219050061. Lots affected: see Urgent Security Notice Model available at http://portal.anvisa.gov.br/wps/wcm/connect/e3e89e804149274293879fa8d08ea2d4/CARTA_CLIENTES_EDWARDS.pdf?MOD=AJPERES.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA.; EDWARDS LIFESCIENCES LLC.

¿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
    1296
  • Fecha
    2013-09-30
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    Through the analysis of post-marketing surveillance data Edwards Lifesciences identified a potential health risk for patients undergoing bypass surgery when using an intravascular anastomotic shunt. Edwards received 23 complaints regarding high shunt adhesion that may interfere with bypass graft suture. In none of the 23 complaints was there any report of injury to the patient. Complaints were first reported in March 2013 for production lots manufactured as of June 2012. Based on this occurrence and potential impact on patients, Edwards is collecting the IVS Shunts models from the aforementioned lots that have not expired. Vascular shunts are designed to create an artificial passageway connecting two temporary main channels to the bloodstream distally at the surgical site, and to maintain blood flow in the cerebral vascular system. These shunts have a silicone body and balloons at the end and proximal end. The balloons are designed to provide shunt fixation in the vessel, with minimal arterial dissection and vessel wall trauma, and at the same time eliminates bleeding around the shunt during operative procedure. Nonconformity is associated with an excessive amount of silicone in Anastaflo Shunt, which can damage the blood vessel by removing the product before making the last stitch. If the overhang is not noticed prior to its use on the patient, it may damage the suture line and result in further surgical repair.
  • Causa
    Excessive amount of silicone in anastaflo shunt, which can damage the blood vessel when removing the product before making the last stitch.
  • Acción
    Product pick-up by EDWARDS LIFESCIENCES TRADE OF PRODUCTS MÉDICO-CIRÚRGICOS LTDA. Locate the products at risk in your inventory, identify them and segregate them to avoid inadvertent use. Wait for the company contact to collect the product.