Events

Cordis OptEase Retrievable Vena Cava Filter 에 대한 현장 안전성 서한

ALIMS (Agencija za lekove i medicinska sredstva)에 따르면, 해당 현장 안전성 서한 는 Serbia 에서 Cordis Europa N.V. 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
  • 날짜
    2013-03-04
  • 사례 출판 날짜
    2013-04-22
  • 사례 국가
    Serbia
  • 사례 출처
    ALIMSA
  • 사례 출처 URL
    https://www.alims.gov.rs/latin/2013/04/22/vazno-obavestenje-o-medicinskom-sredstvu-cordis-optease-retrievable-vena-cava-filter-filter-vena-cava/
  • 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
    Through continuous post-market safety surveillance, cordis has identified a series of recent events in which the optease® retrievable vena cava filter was implanted in the opposite orientation to that specified in the product instructions for use (ifu). a total of fifteen (15) events have been reported since 2006, including four events received in the last six (6) months.Based on cordis’ investigation, cordis has learned the optease® retrievable vena cava filter was placed with the retrieval hook towards the superior vena cava, inadvertently in some cases, or by the implanting physician’s decision in others. in at least four (4) cases, the filter migrated to the right heart; open heart surgery was needed in two cases. no deaths related to this issue have been reported.

Device

Cordis OptEase Retrievable Vena Cava Filter

Manufacturer

Cordis Europa N.V.