Events

IN.PACT Amphirion Drug-Eluting Balloon (DEB) (used for percutaneous transluminal angioplasty of small peripheral arteries)Supplied in Australia under the Special Access Scheme (SAS) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic 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-2013-RN-01153-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-11-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01153-1
  • 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
    Based on data from clinical study, the in.Pact amphirion drug-eluting balloon (deb) did not meet its safety and efficacy endpoints relative to the percutaneous transluminal angioplasty (pta) control. the study also identified a potential safety signal given a trend towards an increased rate of major amputations in the deb study arm. causality between major amputation and use of the in.Pact amphirion deb could not be established or excluded.
  • 조치
    Medtronic is advising hospitals to quarantine all units of the IN.PACT Amphirion DEB that remain in their inventory.

Device

IN.PACT Amphirion Drug-Eluting Balloon (DEB) (used for percutaneous transluminal angioplasty of s...
  • 모델명 / 제조번호(시리얼번호)
    IN.PACT Amphirion Drug-Eluting Balloon (DEB) (used for percutaneous transluminal angioplasty of small peripheral arteries)Supplied in Australia under the Special Access Scheme (SAS)
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA