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
    2017-03-22
  • Event Date Posted
    2017-03-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170322b.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 abbott vascular has issued a medical device safety alert concerning its nc trek rx coronary dilatation catheter, nc traveler rx coronary dilatation catheter, and nc tenku rx ptca balloon catheter. the manufacturer has initiated a voluntary field action regarding specific lots of the nc trek rx coronary dilatation catheter, nc traveler rx coronary dilatation catheter, and nc tenku rx ptca balloon catheter. product from the lots may exhibit difficulty in removing the protective balloon sheath. if excessive force is required to remove the balloon sheath, the sheath may damage the device causing problem with inflating and deflating the balloon. according to the manufacturer, the worldwide frequency of tight sheath removal, inflation and deflation reported events are 0.12%. potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. in one reported case, failure to deflate the balloon necessitated surgery, leading to multiple post-operative complications and death. this action does not affect patients having successfully undergone cardiac procedures using these devices. the affected users are advised to take the following actions: immediately stop using devices from the affected lots, and return all unused products to the manufacturer for replacement. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 march 2017.

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