SMART Vascular Stent System 에 대한 현장 안전성 서한

ALIMS (Agencija za lekove i medicinska sredstva)에 따르면, 해당 현장 안전성 서한 는 Serbia 에서 Cordis Cashel 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
    2017-02-16
  • 사례 출판 날짜
    2017-10-03
  • 사례 국가
  • 사례 출처
    ALIMSA
  • 사례 출처 URL
  • 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
    Following recent complaints and a follow-up investigation, cordis found that the s.M.A.R.T. 5x200mm and 6x200mm was linked to a higher incidence of incidents resulting from difficulty in placing these stents compared to other sizes. the most commonly reported difficulty with the placement of a stent is the inability to place the stent, which led to delays during the procedure due to the preparation of a replacement medical device. however, partial stent placement may cause ischemia or internal bleeding which would require additional intervention. since launching these products in 2013, a total of 3 injuries have been reported worldwide for complaints of stent placement issues (bleeding at the stent insertion site in one case, and causing a thrombus twice) and neither is believed to be in connection with this medical device. however, the causal connection cannot be completely disconnected at this time.

Device

  • 모델명 / 제조번호(시리얼번호)
    numbers SF05200MV; SF05200SV; SF06200MV; SF06200SV lots 34469-39974
  • Manufacturer

Manufacturer