Events

Field Safety Notices about S.M.A.R.T.® Flex sizes 5x200 mm and 6x200 mm

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Cordis®.

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 Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Based on complaints and follow-up investigations, cordis found that the sizes of the 5x200 mm and 6x200 mm cordis® smart® flex cord system (a total of four part numbers) are associated with an increase in incidents involving installation problems, compared to others sizes.   the most commonly mentioned mounting problem is the inability to install the mount, which leads to an extended intervention time due to the preparation of the replacement accessory. partial placement of the abutment may also lead to ischemia or internal bleeding, which would require additional intervention.   since the launch of this product in 2013, there have been a total of three reported cases of patient injuries worldwide related to complaints of placement problems (one case of insertion bleeding and two cases of thrombus formation), which are not likely due to the use of the device. however, we cannot exclude any causal link at this time.

Device

S.M.A.R.T.® Flex sizes 5x200 mm and 6x200 mm
  • Model / Serial
    lot range from 34469 to 39974
  • Manufacturer
    Cordis®

Manufacturer

Cordis®