Events

Safety Alert for EndoBarrier Gastrointestinal Liner System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by GI Dynamics.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-10-06
  • Event Date Posted
    2015-10-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151006c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: gi dynamics endobarrier gastrointestinal liner system the medicines and healthcare products regulatory agency (mhra) of united kingdom has posted a medical device safety alert concerning endobarrier gastrointestinal liner system, packaged, sterile us [part number: 40-10-00624], manufactured by gi dynamics (gid). due to the incidence rate of hepatic abscess (ha) in the united states (us) investigational device exemption endo trial exceeding the established safety threshold of 2%, the study was terminated by gid prior to completion. the manufacturer and the us food and drug administration (fda) have come to a mutual agreement to conclude the endo trial as of 30 july 2015. with seven cases of hepatic abscess in the endo trial, the incidence rate is approximately 3.5%, which exceeds a previously established safety threshold of 2%. the overall historical rate of hepatic abscess in markets outside the us is approximately 0.94% based on experience with approximately 3,200 units shipped commercially since 2009. this rate reflects an increase from 0.49% observed globally two years ago, but is still low and below the 2% threshold established for the treatment. all reported cases of ha that developed after endobarrier implantation have been fully resolved upon device removal. the manufacturer will immediately begin explanting the device from all remaining endo trial participants and closing out the endo trial. the manufacturer expects to complete all explants by the end of october. endobarrier will continue to be available to patients who need it in all countries around the world where it is approved for commercial use. physicians are advised to continue to educate patients on the early signs of ha (e.G., right upper quadrant pain, abdominal pain, fever/chills/malaise) and remind them to seek immediate treatment and resolution to mitigate any complications should they be present. for details, please refer to the mhra website:https://www.Gov.Uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-28-september-to-2-october-2015 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 october 2015.

Device

EndoBarrier Gastrointestinal Liner System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: GI Dynamics EndoBarrier Gastrointestinal Liner System
  • Manufacturer
    GI Dynamics

Manufacturer

GI Dynamics