Alerta De Seguridad O Notificaciones De Seguridad para OPTEASE® retrievable vena cava filter

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Cordis Corporation.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
  • Número del evento
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of serious patient injury from the migration of a wrongly orientated inferior vena cava (ivc) filter. on 8 october 2013 cordis corporation issued an urgent field safety notice recalling 217 distributed lots of the optease retrievable vena cava filter, due to a printing error in the device labelling. the error involved the access site arrow pointing the wrong way on the storage tube for a filter intended to be placed using the femoral approach, and resulted in the filter being implanted upside down. the filter had to be retrieved percutaneously to remove the risk of it migrating towards the patient’s heart, because the filter’s retaining barbs would have provided no migration resistance. the procedure had to be completed using a jugular approach, contrary to the instructions for use, because the retrieval hook was orientated upwards in the cranial direction. the affected optease filters were manufactured between november 2010 and august 2013. cordis has confirmed that all unused filters have now been recalled, and that no other instances of incorrect arrow orientation have been found from inspection of over 10,000 storage tubes manufactured at the same time as distributed product. the mhra is issuing this medical device alert because the manufacturer’s fsn does not have advice on the management of patients already implanted with an optease ivc filter. cranial migration of any ivc filter carries a fatal risk to the patient. although the risk of migration may decrease the longer the implant has been in place as the filter becomes embedded in the caval wall, there are no data to confirm a time at which migration would no longer occur. cordis corporation currently manufactures two distinct models of ivc filter: the trapease ® permanent vena cava filter, not designed to be retreived. it has no retrieval hook and has bi-directional retaining barbs. therefore orientation is not critical. the optease® retrievable vena cava filter, a temporary filter designed to be retrieved within 12 days (after which it is considered a permanent implant). it has retaining barbs that are uni-directional, and must therefore be implanted in one orientation only (see fsn dated 3 april 2013). it incorporates a retrieval hook which should always point in the caudal direction (irrespective of implantation route) to facilitate femoral retrieval, and to ensure that the retaining hooks are securing the filter against migration.
  • Acción
    For all patients implanted with an affected OPTEASE IVC filter: Review retained post-op images to check whether the implanted filter is correctly orientated, which is with the retrieval hook in the caudal direction. Recall for rescreening all patients for whom correct orientation cannot be confirmed. These patients should be recalled as soon as possible, prioritising those with the most recent implants. Weigh the serious risk of filter migration against the risk of a re-intervention for a filter that is implanted upside down. Both risks may vary according to how long the implant has been in place, and should be assessed for each patient individually. Be aware that re-intervention, where considered appropriate, should be undertaken as soon as possible, and would require a jugular approach. Ensure that all IVC filters are correctly orientated prior to loading into the delivery system and insertion into the patient. Note that the filter’s retaining barbs protect against migration in only one direction.


  • Modelo / Serial
  • Descripción del producto
    OPTEASE® retrievable vena cava filter, manufactured by Cordis Corporation. Lots with number 15960131 or below.
  • Manufacturer