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.

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.

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.