Events

Avis De Sécurité sur Endurant II Stent Graft System – Bifurcated

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par Medtronic Inc..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date de publication de l'événement
    2017-03-31
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    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 / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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