Events

Safety Alert for Pipeline Flex, Marathon Flow Directed Micro Catheter, Alligator Retrieval Device, Pipeline Embolization Device

According to National Drugs Administration from El Salvador (DNM), this safety alert involved a device in El Salvador that was produced by Medtronic.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Risk Class
    Class I
  • Date
    2016-12-01
  • Event Country
    El Salvador
  • Event Source
    DNM
  • Event Source URL
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • Notes / Alerts
    Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 data from the U.S. and El Salvador.
  • Extra notes in the data
  • Reason
    The cause of the alert is related to the detachment of the polytetrafluoroethylene (ptfe) coating, which serves to reduce friction between devices and facilitate navigation through the vasculature. the delamination of the layer could possibly lead to an embolic occlusion in the cerebral tilt with the risk of a spill and / or death.
  • Action
    Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment. - Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices

Device

Pipeline Flex, Marathon Flow Directed Micro Catheter, Alligator Retrieval Device, Pipeline Emboli...
  • Model / Serial
    Sanitary DNM Registration Numbers: IM079130062016, IM031905032015, IM026307042016. PIM number:882014
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NDAESDNM