Alerta De Seguridad para Trade name: Core Valve Evolut A / R Transcatheter Valve R //. Technical Name: Cardiac Valve Prosthesis //. ANVISA registration number: 10339190629 //. Risk class: IV (Maximum Risk) //. Affected Model (s) and Batch (s) / Serial Number (s) Affected. Attached distribution list

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.

The recommendations below are intended for physicians / health professionals, and further details of the guidelines can be found in the FA729 Customer Letter: 1) Patient anatomy considerations: Physicians should consider whether complex anatomical configurations, including combinations of two or more traits below, raise the risk of vascular trauma. 2) Procedure Use: During the advancement of the introduction system, enlarge the images sufficiently to allow the tip of the capsule to be viewed relative to the vasculature of the patient. If you observe the tip of the infeed folding system in a different direction from the infeed cap, do not force the infeed. Instead, retract the introduction system to a straight part of the descending aorta, reorient it by rotating the 90 degree introductory system and restart the passage very carefully. 3) Use of the procedure: If significant resistance is encountered during the advance of the introduction system, do not force the passage. Use magnification of fluoroscopy to evaluate the vasculature. If no damage is identified, retract the delivery system to a straight portion of the descending aorta and consider the actions outlined in the FA729 Customer Letter. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link