Events

Recall of Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems(indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms)

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-2017-RN-00306-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-03-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00306-1
  • 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
    Medtronic have identified that a specific subset of endurant/ endurant ii bifurcated stent graft systems have greater susceptibility to permeability variations associated with endoleaks identified during the initial implant procedure. at the time of implant procedure, in the event of an endoleak, this potential permeability variation in the affected subset of stent grafts may cause the physician to categorise a type iv endoleak (which typically self-resolves over time) as an acute type iii fabric endoleak because the leak may appear to be focal or a localised leak as opposed to a diffused leak (blush). this potential misclassification of a type iv endoleak as an acute type iii fabric endoleak may lead to unnecessary secondary interventions to treat the perceived acute type iii endoleak, whereas it could be a type iv endoleak that self-resolves over time. this potential permeability variation observation is limited to a subset of 23mm and 25 mm devices.
  • Action
    Users are advised to identify and quarantine unused Endurant /Endurant II 23mm and 25mm Bifurcated Stent Graft System from the identified subset of models and serial numbers that are in their inventory. Medtronic is also advising that there are no actions required for patients already implanted, as the potential for endoleak misclassification due to permeability variation occurs acutely at implant. Patients who have been implanted with an Endurant /Endurant II 23mm or 25mm Bifurcated Stent Graft System affected by this recall do not require any additional follow up due to this observation and should continue to be monitored in accordance with the standard practice.

Device

Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems(indicated for the endovascula...
  • Model / Serial
    Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems(indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms)Multiple Product and Serial NumbersARTG Numbers: 158456, 197539
  • Product Classification
    Cardiovascular Devices
  • 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