Events

Avis De Sécurité sur Zenith Alpha™

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Cook Medical Europe.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2017-03-22
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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