Events

Absorb GT1 Bioresorbable Vascular Scaffold (BVS) 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Abbott Vascular 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
  • 날짜
    2017-11-01
  • 사례 출판 날짜
    2017-11-01
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171101.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: abbott vascular absorb gt1 bioresorbable vascular scaffold (bvs) the united states food and drug administration (fda) has issued an alert to health care providers to inform the health care community that interim study results through three years from the pivotal clinical trial (absorb iii) continue to show an increased rate of major adverse cardiac events and bvs scaffold thrombosis in patients receiving the absorb gt1 bioresorbable vascular scaffold (bvs), when compared to patients treated with the approved metallic xience drug-eluting stent. the fda was made aware that the manufacturer has stopped global sales of the absorb gt1 bioresorbable vascular scaffold as of 14 september 2017. although health care providers with available inventory may continue to implant the bvs, they should carefully consider its safety and effectiveness and only use it if they believe it is in the best interest of their patients. while the manufacturer has discontinued sales of bvs, they will continue to monitor patients currently enrolled in the absorb iii and absorb iv us clinical studies through five years following bvs implantation. patients enrolled in these studies will be followed through standard practice and care after five years. the fda provided the following recommendations to health care providers: follow the instructions for target heart vessel selection (e.G., avoiding bvs use in small heart vessels) and optimal device implantation that are included in the bvs physician labeling. advise patients experiencing any new cardiac symptoms such as irregular heartbeats, chest pain, or shortness of breath to seek clinical care. for more information about risks associated with the bvs, refer to the bvs physician labeling. advise bvs patients to follow the recommendations for dual antiplatelet therapy (dapt) prescribed by their health care providers. for details, please refer to the fda websites: https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm547256.Htm https://www.Fda.Gov/medicaldevices/safety/letterstohealthcareproviders/ucm582728.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 november 2017.

Device

Absorb GT1 Bioresorbable Vascular Scaffold (BVS)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Abbott Vascular Absorb GT1 Bioresorbable Vascular Scaffold (BVS)
  • Manufacturer
    Abbott Vascular

Manufacturer

Abbott Vascular
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH