Events

Protege EverFlex Self-Expanding Peripheral Stent System containing all size variants of 5mm diameter stent in both 80cm and 120cm delivery catheters. Protege EverFlex Self-Expanding Peripheral Stent System containing all size variants of 200mm length stent in 6, 7, 8mm diameter stent in 120cm delivery catheters. (Vascular prosthetic stent) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 EV3 Australia Pty Limited 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-2012-RN-00867-3
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-08-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00867-3
  • 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
    Ev3 has identified a regulatory compliance issue with the protege everflex self-expanding peripheral stent system range of products. the majority of these products were included in the australian register of therapeutic goods under artg 151132. however, the additional sizes with the smallest diameter stent of 5mm and the 6-8mm stents of greatest length of 200mm were inadvertently released prior to the tga's review and approval for inclusion under artg 151132.
  • 조치
    EV3 Australia is asking hospitals to quarantine the affected stent system in a controlled area. Ev3 is advising clinicians that availability of the affected stent system is limited to patients eligible under the Special Access Scheme. Alternatively, individual clinicians can apply to the TGA to become an Authorised Prescriber.

Device

Protege EverFlex Self-Expanding Peripheral Stent System containing all size variants of 5mm diame...
  • 모델명 / 제조번호(시리얼번호)
    Protege EverFlex Self-Expanding Peripheral Stent System containing all size variants of 5mm diameter stent in both 80cm and 120cm delivery catheters. Protege EverFlex Self-Expanding Peripheral Stent System containing all size variants of 200mm length stent in 6, 7, 8mm diameter stent in 120cm delivery catheters. (Vascular prosthetic stent)Multiple Product Codes
  • Manufacturer
    EV3 Australia Pty Limited

Manufacturer

EV3 Australia Pty Limited
  • 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