Events

Endurant II Stent Graft System – Bifurcated 에 대한 현장 안전성 서한

ALIMS (Agencija za lekove i medicinska sredstva)에 따르면, 해당 현장 안전성 서한 는 Serbia 에서 Medtronic Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 출판 날짜
    2017-03-31
  • 사례 국가
    Serbia
  • 사례 출처
    ALIMSA
  • 사례 출처 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/
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “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