Events

Recall of Lotus Valve System (a transcatheter aortic valve implantation (TAVI) system) Lotus TAVR 23mm

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-2016-RN-00447-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-04-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00447-1
  • 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’s (bsc) review of the post-market data has identified an increase in the number of complaints related to ‘catheter release pin mandrel break’. the failure can occur during sheathing as part of device preparation or re-sheathing during the procedure, if repositioning is required. the release mandrel break is most commonly identified during the valve releasing phase of the procedure. in the event of a broken release mandrel, the physician will re-sheath the valve and replace the device. in addition to the 24 complaints reported during nov 2014 – jan 2016, there were 8 complaints reported in february 2016 related to release mandrel. there has been one complaint event reported in february 2016 which resulted in a patient death. bsc’s investigation concluded that incorrect preparation of a device may contribute to increased opportunity for the release mandrel to break.
  • Action
    Boston Scientific (BSC) is initiating this action to: 1- Provide additional clarification on the instructions for preparing the Lotus Valve System prior to the procedure; and 2- Ensure all certified physicians have received all training necessary for independent implantation of the device, i.e., without the support of a BSC Field Clinical Specialist (FCS). Boston Scientific is advising users that the relevant training manuals have been updated to avoid crimping the mid-section of the valve during sheathing. Boston Scientific Field Clinical Specialist will re-train all cath-lab staff in the revised procedures. Users in "Non Independent" sites are reminded to ensure all procedures are completed with the support of a Boston Scientific Field Clinical Specialist until the site has been designated to be "Independent" by Boston Scientific. This action has been closed-out on 30/01/2017.

Device

Lotus Valve System (a transcatheter aortic valve implantation (TAVI) system) Lotus TAVR 23mm
  • Model / Serial
    Lotus Valve System (a transcatheter aortic valve implantation (TAVI) system) Lotus TAVR 23mmMaterial Number: H749LTV230Catalogue Number: LTV23All batches affectedLotus TAVR 25mmMaterial Number: H749LTV250Catalogue Number: LTV25All batches affectedLotus TAVR 27mmMaterial Number: H749LTV270Catalogue Number: LTV27All batches affectedARTG Number: 260448
  • 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