Events

Safety Alert for Zenith Alpha Thoracic Endovascular Graft

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

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
    2015-02-06
  • Event Date Posted
    2015-02-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150206.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: william cook europe zenith alpha thoracic endovascular graft medical device manufacturer, william cook europe, has issued a field safety notice concerning zenith alpha thoracic endovascular graft [reference number: 2015fa0001]. the manufacturer identified a few cases of distal type i endoleak, migration and aneurysm growth during on-going longer-term follow-up of patients enrolled in the multi-national clinical investigation of the device. these findings were found to be associated with thoracic aneurysms treated with a single proximal component that resulted in a short distal seal length (i.E., less than 20 mm) and likely inadequate (i.E., less than 10%) distal oversizing for the device. the manufacturer has revised the instructions for use to include additional warnings and precautions on the above issues. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 february 2015.

Device

Zenith Alpha Thoracic Endovascular Graft
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: William Cook Europe Zenith Alpha Thoracic Endovascular Graft
  • Manufacturer
    William Cook Europe

Manufacturer

William Cook Europe