Events

Field Safety Notices about Pipeline Embolization Device

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

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
    2012-05-12
  • Event Date Posted
    2013-01-17
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2013/01/17/vazno-obavestenje-o-medicinskom-sredstvu-pipeline-embolization-device-sredstvo-za-embolizaciju-cerebralnih-aneurizmi/
  • 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
    Since commercialization of the pipeline embolization device (ped), covidien has conducted postmarket surveillance of the clinical use of our ped system. our current postmarket data continues to demonstrate morbidity and mortality rates in alignment with those noted in the pufs (pipeline for failed aneurysm) trial that was clinical basis for us commerical approval of the device. rates of major neurologic complications or death in the pufs clinical trial were 5.6% (2.8% for morbidity and 2.8% for mortality). with over 15,000 ped devices implanted to date, the rate of overall morbidity and mortality are 2.6% and 1.6% respectively.

Device

Pipeline Embolization Device

Manufacturer

Covidien
  • 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
    ALIMSA