Events

Safety Alert for CORDIS EXPANDABLE STENT SYSTEM - registration 80145900749 - Lots: See annex .. http://portal.anvisa.gov.br/wps/wcm/connect/f008ce004a269a4ab06db9aa19e2217c/Alerta_1112_Lotes_afetados.pdf?MOD=AJPERES

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA SAÚDE LTDA.

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
    1112
  • Date
    2012-02-13
  • 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
    Cordis has recently identified that some Cordis SMART® CONTROL® Nitinol Stent System products may have small grooves in the package seal. The potential defect was detected during internal testing on non-production products as part of a development project. Further investigation has identified that there are conditions that may cause a seal groove in a small percentage of the products distributed. The compromised seal is not readily apparent to the naked eye. To date, no claims have been reported and are associated with this defect. This recall is not being performed due to adverse medical events. If there is a groove in the seal, loss of the sterile barrier may occur, resulting in the use of a non-sterile device during a procedure. Contamination may expose the patient to an increased risk of infection. If an infection occurs, medical intervention may be necessary to prevent injury or permanent damage. Infection caused by conventional vascular stents is rare. Patients who have had a stent implanted for less than 30 days should be closely monitored for signs of infection. Cordis has conducted a root cause investigation and will resume distribution of the product as soon as corrective actions and / or inspections are implemented. Anvisa follows this action. No related cases were reported in the National System of Notifications for Sanitary Surveillance - NOTIVISA, until the present moment.
  • Reason
    Probability of rupture of sterility in some packages.
  • Action
    • Immediately identify and separate all affected products to ensure they are not used. • Review, complete, sign, and return the attached Confirmation Form, according to the instructions on the form. • Return the affected product in accordance with the enclosed instruction or contact your local sales representative to arrange for the return of the affected product. The replacement product will be provided in the case of a consignment product when the product is available, and the credit will be released to the product in the customer's possession. • Forward this notification to everyone at your service who needs to be informed. • If any product listed below has been shipped to another service, please contact this location to arrange a return. • Be aware of this notification until all affected products in your facility have been returned to Cordis.

Device

CORDIS EXPANDABLE STENT SYSTEM - registration 80145900749 - Lots: See annex .. http://portal.anvi...

Manufacturer

JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA SAÚDE LTDA