Events

Absorb Bioresorbable Vascular Scaffold (BVS) System (Bioresorbable balloon expandable scaffold with bioresorbable polymeric drug coating mounted on a balloon dilatation catheter) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abbott Vascular Division of Abbott Australasia Pty Ltd 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
    RC-2015-RN-01188-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01188-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Abbott vascular (av) has recently published the results of absorb iii, a clinical trial that compared the safety and effectiveness of absorb bvs to the xience, metallic drug eluting stent. learnings from an analysis of the absorb iii data and other published data have identified an impact on clinical outcomes following changes to procedural techniques. implementation of these techniques is expected to facilitate optimal clinical outcomes and reduce the possibility of thrombosis. av will be updating the instructions for use (ifu) with this information.
  • 조치
    Until the updated IFU is available, users are advised to follow the key changes identified in the customer letter while performing lesion sizing and preparation and also, during scaffold deployment to achieve optimal scaffold apposition to the artery wall. AV is also reinforcing the importance of the IFU instructions (including ensuring the vessel size is > 2.0 and < 3.8 mm) and the key changes in letter to facilitate optimal clinical outcomes and reduce adverse events such as restenosis and thrombosis.

Device

Absorb Bioresorbable Vascular Scaffold (BVS) System (Bioresorbable balloon expandable scaffold wi...
  • 모델명 / 제조번호(시리얼번호)
    Absorb Bioresorbable Vascular Scaffold (BVS) System (Bioresorbable balloon expandable scaffold with bioresorbable polymeric drug coating mounted on a balloon dilatation catheter)All sizesARTG Number: 214148
  • Manufacturer
    Abbott Vascular Division of Abbott Australasia Pty Ltd

Manufacturer

Abbott Vascular Division of Abbott Australasia Pty Ltd
  • 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
    DHTGA