Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA.; EDWARDS LIFESCIENCES LLC.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1296
  • Date
    2013-09-30
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    Excessive amount of silicone in anastaflo shunt, which can damage the blood vessel when removing the product before making the last stitch.
  • Action
    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.

Device

ANASTAFLO SHUNT INTRAVASCULAR. Record number 80219050061. Lots affected: see Urgent Security Noti...

Manufacturer

EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA.; EDWARDS LIFESCIENCES LLC