Events

Field Safety Notices about Conformable GORE® TAG® Thoracic Endoprosthesis

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by W. L. Gore & Associates, Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-10-23
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    • since december 2016, gore has received four similar reports of incomplete and / or partial deployments of the conformable tag® device. in each event, the physician observed that half of the conformable tag® device deployed and half remained constrained to the delivery catheter. each of these events occurred during an off-label procedure, but it is unclear at this time how this may have affected the outcomes. engineering evaluations for two returned devices indicate that one partial deployment was the result of an incorrect deployment line stitch pattern and another was the result of deployment line damage of unknown origin. the other two devices have not been returned to gore for evaluation. • there were two serious adverse health consequences and one death reported: – one patient required intra-operative surgical conversion and subsequently died. – one patient required intra-operative surgical conversion and experienced temporary mesenteric and renal ischemia. – one patient required an additional surgical intervention and experienced temporary renal ischemia. – one patient sustained no injuries due to deployment during an open repair. • while incomplete deployments are known adverse events and identified within the instructions for use (ifu), gore has seen an increased frequency of these partial deployment events in conformable tag® devices sold (totaling 0.03% of 12,865 devices distributed*) that were manufactured in the prior year compared to those manufactured earlier. .

Device

Conformable GORE® TAG® Thoracic Endoprosthesis

Manufacturer

W. L. Gore & Associates, Inc.