Events

Field Safety Notices about Ieoa table and size measuring device for mosaic aortic bioprosthesis of the model 305

According to Agency for Medical Products and Medical Devices of Croatia, this field safety notices involved a device in Croatia that was produced by Medtronic Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    2014_medtronic_mosaic_aortic_prosthesis_995
  • Date
    2014-01-23
  • Event Country
    Croatia
  • Event Source
    AMPMDC
  • Event Source URL
    http://www.halmed.hr/en/Medicinski-proizvodi/Sigurnosne-informacije/Sigurnosne-obavijesti-o-medicinskim-proizvodima/2014/Medtronic-Mosaic-Aortic-Prosthesis/995
  • Notes / Alerts
    Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, 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 recall data from the U.S. and Croatia.
  • Extra notes in the data
    The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Medtronic Inc. on the change of the iEOA table and size measuring device for Mosaic aortic bioprosthesis of the model 305 due to reports to higher than expected transvalvular gradients occurred after implantation.
    The manufacturer has informed users that older versions of tables and measuring device will not be distributed anymore.
    Here you may view the safety information addressed to users.

Device

Ieoa table and size measuring device for mosaic aortic bioprosthesis of the model 305

Manufacturer

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
    AMPMDC