Events

Alerte De Sécurité sur 1) NIRoyal Coronary Stents; Premounted Coronary Stent Systems: (2) NIRoyal Elite, (3) NIRoyal Advance, (4) NIRoyal Elite Monorail, (5) NIRoyal Elite Over-the-Wire

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Boston Scientific Ltd.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    681
  • Date
    2002-08-29
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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