Events

Recall of PROMUS Element Plus MONORAIL Everolimus-Eluting Coronary Stent System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Boston Scientific 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-00713-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00713-1
  • 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
    Units of the promus element plus monorail everolimus-eluting coronary stent system has been supplied without the appropriate australian directions for use (dfu) ie, the appropriate content of the pre- and post- procedure anti-platelet regimen is not included in the dfu.
  • Action
    Boston Scientific is undertaking a recall for product correction to provide a copy of the correct DFU for end users to follow. Surgeons who have implanted an affected batch of the device are being provided with a Hazard Alert letter with the information on the correct post-procedure anti-platelet regimen.

Device

PROMUS Element Plus MONORAIL Everolimus-Eluting Coronary Stent System
  • Model / Serial
    PROMUS Element Plus MONORAIL Everolimus-Eluting Coronary Stent SystemMultiple lot numbers affectedARTG Number: 200539
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA