Events

Avis De Sécurité sur Thoracic endovascular prosthesis 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
    2017-06-26
  • 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
    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