Events

Field Safety Notices about Endurant II Stent Graft System – Bifurcated

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

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 Date Posted
    2017-03-31
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2017/03/31/%D0%BE%D0%B1%D0%B0%D0%B2%D0%B5%D1%88%D1%82%D0%B5%D1%9A%D0%B5-%D0%BE-%D0%BF%D0%BE%D0%B2%D0%BB%D0%B0%D1%87%D0%B5%D1%9A%D1%83-%D1%81%D0%B0-%D1%82%D1%80%D0%B6%D0%B8%D1%88%D1%82%D0%B0-%D0%BE%D0%B4%D1%80/
  • 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
    This particular subset of stent grafts is more strongly susceptible to variations in permeability with respect to endoleak (endocurrent) observed during the initial implantation procedure. during the procedure implantation, this variation in permeability may lead the physician to categorize the type iv endoleak (which usually resolves spontaneously over time) as an acute endoleak of type iii material since leakage may act focally or localized instead of diffuse (redness). this classification as acute endoleak of type iii material may lead to unnecessary follow-up interventions. this variation in permeability is limited to the subgroup of products of 23 mm and 25 mm, which are produced with specific production batches of graft materials. this withdrawal does not affect any other models or serial numbers endurant / endurant ii stent-graft system with bifurcation. although the incremental risk associated with the affected endurant / endurant ii sub-stentgraft subgroup with bifurcation is low, there is still the potential for unnecessary follow-up treating a suspected acute type iii endoleak, which may actually be a type iv endoleak, which resolves spontaneously over time. medtronic begins this withdrawal to downplay the above risk by removing unused affected products. medtronic received 20 applications between may 2015 and january 2017 related to the above observed acute leakage of type iii material, which led to additional interventions during procedure. two (2) adverse events were reported. it is reported that the death of one patient occurred 3 weeks after the surgery, but it is unclear whether the death was associated with the subsequent surgery.

Device

Endurant II Stent Graft System – Bifurcated
  • Model / Serial
    ENBF2313C120EE; ETBF2313C166EE; ENBF2313C145EE; ETBF2316C124EE; ENBF2313C170EE; ETBF2316C145EE; ENBF2316C145EE; ETBF2316C166E; ENBF2316C170EE; ETBF2316C166EE; ENBF2513C145EE; ETBF2513C124EE; ENBF2513C170EE; ETBF2513C145EE; ENBF2516C145EE; ETBF2513C166EE; ENBF2516C170EE; ETBF2516C124EE; ETBF2313C124E; ETBF2516C145E; ETBF2313C124EE; ETBF2516C145EE; ETBF2313C145EE; ETBF2516C166E; ETBF2313C166E; ETBF2516C166EE
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • 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