Events

Solitaire Platinum Revascularisation Device 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Covidien 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-2017-RN-01107-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-08-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01107-1
  • 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
    Medtronic is advising that the instructions for use (ifu) included with solitaire platinum revascularisation devices supplied to date do not have correct information regarding indication for use in australia as approved by the tga:the solitaire platinum revascularisation device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (iv t-pa). endovascular therapy with the device should be started within 6 hours of symptom onset; and the device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. patients who are ineligible for iv t-pa or who fail iv t- pa therapy are candidates for treatment.
  • 조치
    Refer to the Instructions for Use included with the customer letter. Continued use of the Solitaire Platinum product as per the TGA approved indication for use is permissible. Complete the Customer Confirmation form supplied with the customer letter and fax it to Medtronic. Share this notification and the included Instructions for Use with others as appropriate, and contact Medtronic Territory Managers with any questions related to this product recall.

Device

Solitaire Platinum Revascularisation Device
  • 모델명 / 제조번호(시리얼번호)
    Solitaire Platinum Revascularisation DeviceProduct Codes: SRD3-4-20-10, SRD3-4- 40-10, SRD3-6-20-10 and SRD3-6-40-10ARTG Number: 284964
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien 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