Events

Field Safety Notices about 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
    2017-03-22
  • 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
    With this safety announcement, we would like to remind you of several aspects of the new version of the instruction manual (nzu) for thoracic endovascular insertion of zenith alpha ™. these updates are crucial in the use of the thoracic aortic thoracic aortic disorder (tpta) device, which is now covered by the newly approved indication for individual lesions of a descending thoracic aorta. the security notice is for informational purposes only. no devices need to be returned, and patients already treated for tpta should be monitored in accordance with current nzus, as follow-up has not been altered. in a clinical trial evaluating the use of a tpta device (without occlusion, adverse clinical consequences, or the need for open surgery / bypass), an incidental thrombus was inserted in the insert during ongoing monitoring in approximately 25% of patients. the literature cites incidence insertion thrombus (including tpta treatment) in the range of 15–40% .1,2,3,4,5 occurrence of insertion occlusion (requiring open surgery / bypass) were also detected after endovascular treatment for tpta.

Device

Zenith Alpha™

Manufacturer

Cook Medical Europe