Events

Alerte De Sécurité sur Endodontic Endodontic System II - Endoprosthesis System Technical Name: Vascular Endoprosthesis ANVISA Registration Number: 10339190330/10339190508 Hazard Class: IV Model Affected: ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C145EE; ENBF2516C170EE; ETBF2313C124E; ETBF2313C124EE; ETBF2313C145EE; ETBF2313C166E; ETBF2313C166EE; ETBF2316C124EE; ETBF2316C145EE; ETBF2316C166E; ETBF2316C166EE; ETBF2513C124EE; ETBF2513C145EE; ETBF2513C166EE; ETBF2516C124EE; ETBF2516C145E; ETBF2516C145EE; ETBF2516C166E; ETBF2516C166EE.

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 MEDTRONIC COMERCIAL LTDA; MEDTRONIC IRELAND; MEDTRONIC MEXICO; MEDTRONIC INC.

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
    2214
  • Date
    2017-03-02
  • 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
    There is no action required for patients already implanted, since the potential for incorrect classification of endoleak by variation of permeability occurs acutely in the implant. Patients who received implants from the 23 mm or 25 mm Endurant / Endurant II Bent Endotracheal System Implanted by this recall do not require any additional monitoring because of this action and should continue to be monitored in accordance with their standard practice. #### UPDATED ON 7/24/2017, the company submitted the field action completion report proving the sending of the safety notice to the client and collection of the equipment informed.
  • Cause
    Medtronic is initiating a voluntary recall of a subset of the endurant / endurant ii bifurcated endoprosthesis systems of models (see appendix a) and specific serial numbers. this specific subset of endoprostheses is more susceptible to variations in permeability that may be associated with endoleaks observed during the initial implant procedure. at the time of the implant procedure, this variation of permeability may cause the physician to characterize a type iv endoleak (which usually resolves over time) as an acute type iii tissue endoleak, as the leak may appear to be focal or localized leakage as opposed to diffuse leakage (redness). incorrect classification as an acute type iii tissue endoleak may lead to unnecessary secondary interventions.
  • Action
    Field Action Code FA758 triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA. Company will collect.

Device

Endodontic Endodontic System II - Endoprosthesis System Technical Name: Vascular Endoprosthesis A...

Manufacturer

MEDTRONIC COMERCIAL LTDA; MEDTRONIC IRELAND; MEDTRONIC MEXICO; MEDTRONIC INC
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA