Events

Avis De Sécurité sur Cordis OptEase Retrievable Vena Cava Filter

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par Cordis Europa N.V..

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
    2013-03-04
  • Date de publication de l'événement
    2013-04-22
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2013/04/22/vazno-obavestenje-o-medicinskom-sredstvu-cordis-optease-retrievable-vena-cava-filter-filter-vena-cava/
  • Notes / Alertes
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notes supplémentaires dans les données
  • Cause
    Through continuous post-market safety surveillance, cordis has identified a series of recent events in which the optease® retrievable vena cava filter was implanted in the opposite orientation to that specified in the product instructions for use (ifu). a total of fifteen (15) events have been reported since 2006, including four events received in the last six (6) months.Based on cordis’ investigation, cordis has learned the optease® retrievable vena cava filter was placed with the retrieval hook towards the superior vena cava, inadvertently in some cases, or by the implanting physician’s decision in others. in at least four (4) cases, the filter migrated to the right heart; open heart surgery was needed in two cases. no deaths related to this issue have been reported.

Device

Cordis OptEase Retrievable Vena Cava Filter

Manufacturer

Cordis Europa N.V.