Events

Recall of Conformable GORE TAG Thoracic Endoprosthesis

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by W L Gore & Associates (Australia) 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-01255-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-10-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01255-1
  • 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
    W.L. gore has received 4 reports of incomplete and/or partial deployment of the conformable gore tag device during endovascular procedures. in each event, half the device deployed and half remained constrained to the delivery catheter. there have been 2 serious adverse health consequences and 1 death related to this issue.New warnings and precautions are being added to the instructions for use (ifu):- if abnormal or inconsistent deployment line resistance is felt during deployment initiation, stop deployment action immediately. if device remains constrained, remove device through the introducer sheath. if resistance is felt during removal through the sheath, stop and withdraw device and introducer sheath together.- if the device is in a partially deployed state and remains attached to the catheter, physicians should strongly consider conversion to immediate open surgical repair to avoid additional procedure time and potential harm from additional endovascular manoeuvres.
  • Action
    Gore is providing users with updated Instructions for Use (IFU) including additional warnings and precautions. There are no actions required for patients already implanted with a Conformable TAG Device. Patients who have been implanted with a device do not require any change to their usual follow-up plan, and should continue to be monitored in accordance with standard practice.

Device

Conformable GORE TAG Thoracic Endoprosthesis
  • Model / Serial
    Conformable GORE TAG Thoracic EndoprosthesisCatalogue Numbers: TGE212110, TGE262610, TGE282810, TGE282815, TGE313110, TGE313115, TGE343410, TGE343415, TGE343420, TGE373710, TGE373715, TGE373720, TGE404010, TGE404015, TGE404020, TGE454510, TGE454515, TGE454520, TGE262110 and TGE312610ARTG Number: 157814
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    W L Gore & Associates (Australia) Pty Ltd

Manufacturer

W L Gore & Associates (Australia) Pty Ltd