Safety Alert for Trade name: Thoracic Gastro TAG Endoprosthesis. Technical name: Endoprosthesis (vascular). ANVISA registration number: 80067930032. Risk class: IV. Model Affected: AW1346-PT3. Serial Numbers Affected: N / A

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.

Gore is updating the Device Instructions for Use to include the following warnings and precautions: (1) If you feel the abnormal or inconsistent resistance of the discharge line during the initiation of the delivery, STOP the delivery action immediately. If the device remains restricted, remove the device through the introducer sheath. If you feel resistance during the removal of the restricted endoprosthesis, stop and remove the device and the introducer sheath together; (2) If the device is restricted or attached to the catheter and remains in a partial delivery state, the physician should seriously consider immediate conversion to open surgical repair to avoid additional procedure time and potential impairment of additional endovascular maneuvers. Gore also recommends adhering to approved device prompts and reviewing current device warnings on the UI. The full Use Instructions should be reviewed for all indications, contraindications, instructions, warnings, precautions, etc. There are no actions required for patients who received the device. Patients who wish to report 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 Additional information: - Date of identification of the problem by the company: 07/31/2017 - Date of notification notice for Anvisa: 10/17/2017 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "