Events

Field Safety Notices about Thoracic endovascular prosthesis Zenith Alpha ™

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 Cook Medical Europe.

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
    2017-06-26
  • 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
    As described in a recent 2017fa0001 safety corrective action notice of march 2017 regarding zenith alpha ™ thoracic endovascular prosthesis, we have received complaints involving product thrombosis / occlusion when used to treat topical thoracic aortic injury (btai). since then, cook medical has received additional complaints with the same issue. although complaints have been sent by patients treated prior to the publication of the abovementioned safety remedy notice, cook medical is beginning to voluntarily correct ifus and voluntarily withdraw certain sizes of zenith alpha ™. thoracic endovascular prosthesis from the market. .

Device

Thoracic endovascular prosthesis Zenith Alpha ™

Manufacturer

Cook Medical Europe