Events

Field Safety Notices about 200 mm sinus-SuperFlex-635 self-expanding nitinol stent system

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 optimed Medizinische Instrumente GmbH.

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
  • 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
    This corrective action is based on the investigation of field complaints which indicates an increased number of deployment issues of sinus superflex-635 stents with 200 mm length. non-deployments were reported as well partial deployments of the stent. partially deployed stents may require an additional intervention by a doctor due to stent elongation or fracture. this recall does not affect any patient with an implanted stent of this length since this problem may only occur during the implantation of the device. .

Device

200 mm sinus-SuperFlex-635 self-expanding nitinol stent system
  • Model / Serial
    8606-6200/ sinus-SuperFlex-635, Stent system, 6x200 mm, 6F/ 75 cm, .035i, application device 8606-7200/ sinus-SuperFlex-635, Stent system, 6x200 mm, 6F/ 120 cm, .035i, application device 8607-6200/ sinus-SuperFlex-635, Stent system, 7x200 mm, 6F/ 75 cm, .035i, application device 8607-7200/ sinus-SuperFlex-635, Stentsystem, 7x200 mm, 6F/ 120 cm, .035i, application device
  • Manufacturer
    optimed Medizinische Instrumente GmbH

Manufacturer

optimed Medizinische Instrumente GmbH