Events

endovascular medical device - Nellix stent 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Endologix Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    I1611-531
  • 사례 연번
    2015DM-0013350
  • 날짜
    2016-11-24
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=113
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer reports that it has detected that the frequency of displacement of the implants, of endoleaks or the size of the aneurysm has been higher than expected, therefore, it has decided to update the instructions of use with more detailed information of the indications of use, selection criteria of the patient and optimal practices for the intervention, avoiding that its misuse leads to the occurrence of potentially adverse events on patients.

Device

endovascular medical device - Nellix stent
  • 모델명 / 제조번호(시리얼번호)
    N10-100, N10-120, N10-140, N10-160, N10-180, N10-110, N10-130, N10-150, N10-170
  • 제품 설명
    The abdominal aortic endograft "NELLIX ENDO VASCULAR ANEURYSM SEALING SYSTEM" (endo vascular system for infrarenal aortic aneurysm NELLIX) consists of a cobalt chromium stent, expandable balloon covered with PTFE (high density polytetrafluoroethylene expanded) and a bag (called endobag) The NELLIX ENDO VASCULAR ANEURYSMSEALING SYSTEM (NELLIX infrarenal aneurysm system) is indicated for the treatment of infrarenal abdominal aortic aneurysm NELLIX System Removal is performed by introducing two stent, each one with a reinforced polyester sheath. Through each femoral artery using a "catheter-based" delivery system, after implantation of both NELLIX stents crossing the aneurysm, the stents are expanded by balloon and then a polymer is injected into the bags that cover the stents in order to fill the space of the aneu blood lumen risma out of the losstents, thus excluding and sealing the aneurysm. The use of "NELLIX ENDO VASCULAR ANEURYSM SEALINGSYSTEM" (system with endovascular seal for infrarenal aortic aneurysm NELLIX) is exclusive for usopor trained professionals and qualified institutions.
  • Manufacturer
    Endologix Inc

Manufacturer

Endologix Inc