Events

Recall of 3f Enable Aortic Bioprosthesis - Model 6000 Supplied in Australia under either Special Access Scheme, as an Authorised Prescriber or under a Clinical Trial

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-01230-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-11-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01230-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    As of 31 october 2014 medtronic has received 17 reported events relating to valve migration (valve migration is defined as a partial or complete displacement or tilting of the valve from its original implant location.), representing an occurrence rate of less than 0.55% based on the number of devices distributed. while many of these events occurred during or immediately post-implant with no patient harm reported, in some cases, valve migration has required additional surgical intervention, which in three instances contributed to eventual patient death.
  • Action
    Medtronic is recommending that two guiding sutures should be utilised during implantation of the valve instead of one guiding suture as noted in the current version of the IFU. The IFU will be updated accordingly; in the meantime, surgeons should reference the updated instructions provided in letter and associated training materials provided when using the 3f Enable Aortic Bioprosthesis. Medtronic is also recommending that doctors continue to follow standard practice of performing an echocardiogram on all patients who receive a 3f Enable Aortic Bioprosthesis prior to discharge, as well as performing routine patient follow-up including physical exam. No additional actions are recommended at this time. For more information please see http://www.tga.gov.au/alert/3f-enable-aortic-bioprosthesis-model-6000 This action has been closed-out on 18/03/2016.

Device

3f Enable Aortic Bioprosthesis - Model 6000 Supplied in Australia under either Special Access Sch...
  • Model / Serial
    3f Enable Aortic Bioprosthesis - Model 6000Supplied in Australia under either Special Access Scheme, as an Authorised Prescriber or under a Clinical Trial
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA