Events

Field Safety Notices about SMART Vascular Stent System

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

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
    2017-02-16
  • Event Date Posted
    2017-10-03
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2017/03/10/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-smart-vascular-stent-system/
  • 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
    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
  • Model / Serial
    numbers SF05200MV; SF05200SV; SF06200MV; SF06200SV lots 34469-39974
  • Manufacturer
    Cordis Cashel

Manufacturer

Cordis Cashel