Events

Recall of Medtronic EnVeo R Delivery Catheter System (DCS)(Supplied as part of the Evolut R System used for the Transcatheter Valve Therapy (TVT))

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-2016-RN-01015-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-08-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01015-1
  • 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
    This action has been undertaken to inform users with important information regarding the potential for vascular trauma with the use of the medtronic enveo r dcs. while the reports of vascular trauma received by medtronic have been infrequent - 39 events per 24,012 sales, they have included 19 deaths. medtronic’s observed rate for vascular trauma is lower than the tvt registry reports in the journal of the american college of cardiology (holmes, et al), which highlighted annular dissection and aortic disruption rates of 0.2% and 0.4% respectively. (while this data is not provided for the purpose of direct comparison of the incidence of vascular trauma with the use of the enveo r dcs due to differences in the event definitions and data collection methods, this data does provide relevant context for the observed incident rate). the tga is continuing its review of the issue together with medtronic and further communication on this matter may be provided at a later stage if needed.
  • Action
    Medtronic’s investigation identified multiple recommendations to reduce the rate of vascular trauma events which includes Physicians to consider complex anatomical configurations which could increase the risk of vascular trauma and death. Also, Physicians are advised during advancement of the delivery system, to magnify images sufficiently to enable visualisation of the capsule tip relative to the patient’s vasculature. If the delivery system tip is observed to bend in a different direction relative to the delivery system capsule, do not force passage. If significant resistance is encountered during advancement of the delivery system, do not force passage. Use increased fluoroscopic magnification to assess the vasculature. More information about how to undertake patient selection and ways to progress the procedure in difficulty cases are provided in the letter to users. The Evolut R System Instructions for Use (IFU) will also be updated appropriately consistent with this action. This action has been closed-out on 16/05/2017.

Device

Medtronic EnVeo R Delivery Catheter System (DCS)(Supplied as part of the Evolut R System used for...
  • Model / Serial
    Medtronic EnVeo R Delivery Catheter System (DCS)(Supplied as part of the Evolut R System used for the Transcatheter Valve Therapy (TVT))Models: ENVEOR-L, ENVEOR-L-CSupplied under Clinical Trial Notification and Special Access Schemes
  • 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