Events

Safety Alert for 1) NIRoyal Coronary Stents; Premounted Coronary Stent Systems: (2) NIRoyal Elite, (3) NIRoyal Advance, (4) NIRoyal Elite Monorail, (5) NIRoyal Elite Over-the-Wire

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific Ltd.

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
    681
  • Date
    2002-08-29
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The uk medical devices agency (mda) has issued a product alert after the manufacturer has received 9 alerts of radial stent fractures, coronary endoprosthesis systems. the fractures occurred between 3 weeks and 9 months after implantation. in 8 cases, the patients presented with recurrent angina. the manufacturer issued a product information alert to users dated june 2002.
  • Action
    MDA recommends the following to health professionals: (1) be aware of the possibility of a radial fracture if patients implanted with the above stent grafts present with angina. No change to clinical management is indicated for asymptomatic patients. (2) report all suspected or known cases of radial fracture in the endoprostheses to the manufacturer, Inquiries to the manufacturer should be addressed to the local representative, or directly to Brian Howlett or Peter Dekkers, Boston Scientific Ltd, by mail at the address given below, by telephone (0172) 779-7608, or by fax at (0172) 786 5862.

Device

1) NIRoyal Coronary Stents; Premounted Coronary Stent Systems: (2) NIRoyal Elite, (3) NIRoyal Adv...

Manufacturer

Boston Scientific Ltd
  • Source
    ANVSANVISA