Events

Field Safety Notices about Cordis OptEase Retrievable Vena Cava Filter

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Cordis Europa N.V..

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
    2013-03-04
  • Event Date Posted
    2013-04-22
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2013/04/22/vazno-obavestenje-o-medicinskom-sredstvu-cordis-optease-retrievable-vena-cava-filter-filter-vena-cava/
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.