Events

Alerte De Sécurité sur Commercial Name: NITINOL CORDIS STENTS (Stent for peripheral arteries), Registry 80145901077. Risk classification IV-Maximum Risk. Lots affected: 172 lots (description of the attached lots, next to the letter to the clients)

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 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Cordis Corporation.

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
    1910
  • Date
    2016-06-14
  • 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
    Recommendations to users and patients: Check the inventory immediately to confirm if you have any of the affected lot units. Identify and separate the units of the affected lots so as to ensure that the affected product is not used. Check all the places of storage and use.
  • Cause
    Based on recent complaints and subsequent investigation, the company detected that products manufactured between april 27, 2015 and november 22, 2015 are associated with an increase in the frequency of incidents of difficulty of placement and in some cases separation of the rod of the external limb resulting in the impossibility of implanting the stent or in the possibility of partial placement of the stent. considering the risk analysis of the product, the potential impact of the impossibility of implanting the stent or the possibility of partially implanting the stent include a delay during the procedure while a replacement device is prepared; vessel injuries requiring unplanned percutaneous or surgical intervention to prevent injury or permanent disability; or in more severe cases, transient ischemic attack or stroke.
  • Action
    Action code 16000079. Letter to customers //// Collection.

Device

Commercial Name: NITINOL CORDIS STENTS (Stent for peripheral arteries), Registry 80145901077. Ris...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Cordis Corporation