Events

Avis De Sécurité sur SMART Vascular Stent System

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 Cashel.

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
    2017-02-16
  • Date de publication de l'événement
    2017-10-03
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2017/03/10/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-smart-vascular-stent-system/
  • 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
    Following recent complaints and a follow-up investigation, cordis found that the s.M.A.R.T. 5x200mm and 6x200mm was linked to a higher incidence of incidents resulting from difficulty in placing these stents compared to other sizes. the most commonly reported difficulty with the placement of a stent is the inability to place the stent, which led to delays during the procedure due to the preparation of a replacement medical device. however, partial stent placement may cause ischemia or internal bleeding which would require additional intervention. since launching these products in 2013, a total of 3 injuries have been reported worldwide for complaints of stent placement issues (bleeding at the stent insertion site in one case, and causing a thrombus twice) and neither is believed to be in connection with this medical device. however, the causal connection cannot be completely disconnected at this time.

Device

SMART Vascular Stent System
  • Modèle / numéro de série
    numbers SF05200MV; SF05200SV; SF06200MV; SF06200SV lots 34469-39974
  • Manufacturer
    Cordis Cashel

Manufacturer

Cordis Cashel