Events

1) NIRoyal Coronary Stents; Premounted Coronary Stent Systems: (2) NIRoyal Elite, (3) NIRoyal Advance, (4) NIRoyal Elite Monorail, (5) NIRoyal Elite Over-the-Wire 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Boston Scientific Ltd 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
    681
  • 날짜
    2002-08-29
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    The uk medical devices agency (mda) has issued a product alert after the manufacturer has received 9 alerts of radial stent fractures, coronary endoprosthesis systems. the fractures occurred between 3 weeks and 9 months after implantation. in 8 cases, the patients presented with recurrent angina. the manufacturer issued a product information alert to users dated june 2002.
  • 조치
    MDA recommends the following to health professionals: (1) be aware of the possibility of a radial fracture if patients implanted with the above stent grafts present with angina. No change to clinical management is indicated for asymptomatic patients. (2) report all suspected or known cases of radial fracture in the endoprostheses to the manufacturer, Inquiries to the manufacturer should be addressed to the local representative, or directly to Brian Howlett or Peter Dekkers, Boston Scientific Ltd, by mail at the address given below, by telephone (0172) 779-7608, or by fax at (0172) 786 5862.

Device

1) NIRoyal Coronary Stents; Premounted Coronary Stent Systems: (2) NIRoyal Elite, (3) NIRoyal Adv...

Manufacturer

Boston Scientific Ltd
  • Source
    ANVSANVISA