Events

Recall of Lotus Valve System Material Description: LOTUS TAVR 23mm, H749LTV230

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-2017-RN-00291-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00291-1
  • 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
    Boston scientific has received higher than anticipated number of reports of early pin release prior to locking the valve in the final position. if this occurs, the valve is unable to be fully locked, which requires the valve to be re-sheathed and removed from the patient prolonging the procedure. removal of the valve was successful in all but one case where the valve embolised and was secured in the descending aorta. all patients were successfully treated with another valve, except for one reported case where the affected valve was removed, but an aortic dissection occurred during implantation of the second valve whereby the patient subsequently died.Please note that there are no safety concerns for patients who have previously received a lotus valve and the issue does not impact the performance of the implanted valve. it is only a potential issue during the implant procedure itself.
  • Action
    Boston Scientific (BSC) is advising users to immediately discontinue use of and segregate affected products. Users are further advised to immediately remove all affected products from their inventory and quarantine the affected stock in a secure location prior to their return to BSC.

Device

Lotus Valve System Material Description: LOTUS TAVR 23mm, H749LTV230
  • Model / Serial
    Lotus Valve System Material Description: LOTUS TAVR 23mm, H749LTV230Batch Number: 19634742Material Description: LOTUS TAVR 25mm, H749LTV250Batch Number: 19520317, 19696773,19520319 and 19696774 Material Description: LOTUS TAVR 27mm, H749LTV270Batch Number: 19686549 and 19978598 ARTG Number: 260448
  • Product Classification
    Cardiovascular Devices
  • 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