Events

Endologix Nellix Endovascular Aneurysm Sealing System 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Endologix, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    20039
  • 사례 시작날짜
    2016-04-19
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: eVas Medical, 73 Churchill Road, Murrays Bay, Auckland 0630
  • 원인
    Updated instructions for use (ifu) for the nellix endovascular aneurysm sealing system., feature that differentiates nellix from other aaa endovascular devices is the use of a 2-part water soluble polymer that is used to fill the aneurysmal space. during the nellix procedure, polymer is dispensed through fill tubes within the catheter into endobags which surround the stent grafts. the polymer is introduced in a liquid form and begins to crosslink as soon as the components are mixed. complete crosslinking occurs inside the endobags 3 to 5 minutes after filling has been completed. the polymer will not crosslink in the fill tubes, as long as there is, continuous flow of the solution. once the polymer stops moving through the fill tubes, crosslinking can occur in 30 seconds within the fill tubes. if the polymer cures in the fill tubes, it can impede further introduction of polymer.Utilization of the secondary fill option (outline din ifu) is necessary to safely compete the filling process.
  • 조치
    Instructions for use to be updated

Device

Endologix Nellix Endovascular Aneurysm Sealing System
  • 모델명 / 제조번호(시리얼번호)
    Model: N10-100, N10-110, N10-120, N10-130, N10-140, N10-150, N10-160, N10-170,, Affected:
  • Manufacturer
    Endologix, Inc.

Manufacturer

Endologix, Inc.