Safety Alert for PIPELINE EMBOLIZING DEVICE - Registration 80301610006 - MODELS / LOTS AFFECTED: VIDE ANNEX .. http://portal.anvisa.gov.br/wps/wcm/connect/f4094c804e37c340a02cb3c09d49251b/Lote_Afetados_no_Brasil.pdf?MOD=AJPERES

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by EV3 COMÉRCIO DE PRODUTOS ENDOVASCULARES DO BRASIL LTDA..

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
    1224
  • Date
    2013-01-17
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    The company clarifies that such difficulties usually occur in patients with tortuous or restrictive anatomy. Therefore, patient selection and device use following the guidelines outlined in the Instructions for Use are critical. Anvisa follows this Field Action. See attached Customer Letter. http://portal.anvisa.gov.br/wps/wcm/connect/1b2139004e37c2c3a023b3c09d49251b/Carta_ao_Cliente.pdf?MOD=AJPERES####ERRORAMENTO - 03/12/2013 - The company forwards the Report of Completion of the Field Action, having communicated all its clients. ####
  • Reason
    The device may not readily disengage from the capture / protection coil and may not open completely and attach to the wall of the vessel. see attached customer letter. http://en.Wikipedia.Org/w/index.Php/.
  • Action
    The company recommends to users that: If there is excessive friction during insertion of the supply system at any time during the use of the PED, carefully remove the whole system simultaneously (microcatheter and delivery system). See attached Customer Letter. http://en.wikipedia.org/w/index.php/

Manufacturer

  • Manufacturer Parent Company (2017)
  • 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