Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC COMERCIAL LTDA; MEDTRONIC IRELAND; MEDTRONIC MEXICO; MEDTRONIC INC.

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
    2214
  • Date
    2017-03-02
  • 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
    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.
  • Reason
    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
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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