Events

Recall of CoreValve AccuTrak Delivery Catheter System (DCS) (Intended to deliver CoreValve Transcatheter Aortic Valve, which is designed to treat severe aortic valve stenosis without open-heart surgery or surgical removal of the native valve)

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-2013-RN-01253-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01253-1
  • 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 has received thirty-eight (38) reported nose cone separation events (.08 percent of implant procedures); five (5) of these reported events (.01 percent of implant procedures) led to the need for surgical intervention. a thorough review and investigation of the reported events has identified that a majority of these reported events occurred in situations cautioned against in current labelling. in addition, medtronic has determined that the following situations can lead to nose cone separations:-using the corevalve accutrak dcs to retrieve (remove) a partially deployed valve.- removing the corevalve accutrak dcs from the patient, after valve deployment, without fully closing the corevalve accutrak dcs capsule. -continuing to pull on the corevalve accutrak dcs if increased resistance is felt at the vessel introducer, the introducer’s hemostatic valve, or other structure during corevalve accutrak dcs retrieval.
  • Action
    To reduce the occurrence of nose cone separations, Medtronic is modifying the instructions for use (IFU) and training materials for CoreValve AccuTrak DCS models DCS-C4-18Fr and DCS-C4-18Fr-23. Medtronic is advising that physicians implement the updated IFU recommendations to reduce occurrences of nose cone separation events during the CoreValve implant procedure.

Device

CoreValve AccuTrak Delivery Catheter System (DCS) (Intended to deliver CoreValve Transcatheter Ao...
  • Model / Serial
    CoreValve AccuTrak Delivery Catheter System (DCS) (Intended to deliver CoreValve Transcatheter Aortic Valve, which is designed to treat severe aortic valve stenosis without open-heart surgery or surgical removal of the native valve)Models DCS-C4-18Fr and DCS-C4-18Fr-23Supplied in Australia under the Clinical Trial Notification (CTN) and Authorised Prescriber Schemes
  • 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