Events

Medtronic EnVeo R Delivery Catheter System (DCS)(Supplied as part of the Evolut R System used for the Transcatheter Valve Therapy (TVT)) 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-2016-RN-01015-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-08-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01015-1
  • 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
    This action has been undertaken to inform users with important information regarding the potential for vascular trauma with the use of the medtronic enveo r dcs. while the reports of vascular trauma received by medtronic have been infrequent - 39 events per 24,012 sales, they have included 19 deaths. medtronic’s observed rate for vascular trauma is lower than the tvt registry reports in the journal of the american college of cardiology (holmes, et al), which highlighted annular dissection and aortic disruption rates of 0.2% and 0.4% respectively. (while this data is not provided for the purpose of direct comparison of the incidence of vascular trauma with the use of the enveo r dcs due to differences in the event definitions and data collection methods, this data does provide relevant context for the observed incident rate). the tga is continuing its review of the issue together with medtronic and further communication on this matter may be provided at a later stage if needed.
  • 조치
    Medtronic’s investigation identified multiple recommendations to reduce the rate of vascular trauma events which includes Physicians to consider complex anatomical configurations which could increase the risk of vascular trauma and death. Also, Physicians are advised during advancement of the delivery system, to magnify images sufficiently to enable visualisation of the capsule tip relative to the patient’s vasculature. If the delivery system tip is observed to bend in a different direction relative to the delivery system capsule, do not force passage. If significant resistance is encountered during advancement of the delivery system, do not force passage. Use increased fluoroscopic magnification to assess the vasculature. More information about how to undertake patient selection and ways to progress the procedure in difficulty cases are provided in the letter to users. The Evolut R System Instructions for Use (IFU) will also be updated appropriately consistent with this action. This action has been closed-out on 16/05/2017.

Device

Medtronic EnVeo R Delivery Catheter System (DCS)(Supplied as part of the Evolut R System used for...
  • 모델명 / 제조번호(시리얼번호)
    Medtronic EnVeo R Delivery Catheter System (DCS)(Supplied as part of the Evolut R System used for the Transcatheter Valve Therapy (TVT))Models: ENVEOR-L, ENVEOR-L-CSupplied under Clinical Trial Notification and Special Access Schemes
  • 의료기기 분류등급
    Cardiovascular Devices
  • 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