Events

Safety Alert for AccuTrak Intravascular Catheter System DCS (CoreValve System accessory). Anvisa Registry n ° 10339190448.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC COREVALVE LLC; Medtronic Comercial 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
    1339
  • Date
    2013-12-11
  • 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
    Medtronic has identified that the following situations may lead to conical tip separation: (1) Using CoreValve AccuTrak DCS to recover (remove) a partially implanted valve; (2) Remove the CoreValve AccuTrak DCS from the patient after valve implantation without completely closing the CoreValve AccuTrak DCS capsule; (3) Continue to pull the CoreValve AccuTrak DCS if resistance increase is felt in the vessel introducer, hemostatic valve of the introducer, or other structure during recovery of the CoreValve AccuTrak DCS; (4) To reduce the occurrence of cone-tip separation, the company is modifying the DCS-C4-18Fr and DCS-C4-18Fr-23 instructions for use (IFU) and CoreValve AccuTrak DCS training materials; however, no return of the product is required.
  • Reason
    Safety alert to reduce the possibility of separating the tapered end of the device.
  • Action
    Carefully read the manufacturer's instructions (Medtronic) in the Alert Message and pass the information to users of the surgeon product). Access the Medtronic Alert Message at: http://portal.anvisa.gov.br/wps/wcm/connect/abc4e8004228b5f28a33ab6d490f120b/Aviso+Urgente.pdf?MOD=AJPERES.

Device

AccuTrak Intravascular Catheter System DCS (CoreValve System accessory). Anvisa Registry n ° 1033...

Manufacturer

MEDTRONIC COREVALVE LLC; Medtronic Comercial Ltda.
  • 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