Events

Safety Alert for Relay Thoracic Aortic Endoprosthesis with Transport Release System - Model: Relay and Relay NBS - ANVISA Registration No. 80003610282

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Bolton Medical Espanha S.L.U.

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
    1424
  • Date
    2014-09-12
  • 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
    1. Upon reaching the intended proximal access zone, visually confirm that the distal marking bands of the stent can be seen approximately 2 cm out of the outer primary sheath. 2. If the distal marking bands of the stent do not appear to have come out of the External Primary Sheath, while in Position 1, grasp the Stationary Gray Stamping Tweezers while pulling back the Black Stationary Tweezer until the marking bands distal from the stent exit of the External Primary Sheath by approximately 2 cm.
  • Reason
    A difficulty was observed in the handling of the prosthesis transport system as set forth below: it was observed that in a small number of cases, the internal secondary sheath may not have completely exited the external primary sheath upon reaching the black line. in this situation, the distal end of the stent will also remain inside the external primary sheath. failure to recognize this condition prior to deployment could lead to deployment difficulties or deployment failures. there is no impact on devices already deployed.
  • Action
    Updating, correcting or supplementing the instructions for use.

Device

Relay Thoracic Aortic Endoprosthesis with Transport Release System - Model: Relay and Relay NBS -...

Manufacturer

Bolton Medical Espanha S.L.U