Events

CoreValve AccuTrak Delivery Catheter System (DCS) (Intended to deliver CoreValve Transcatheter Aortic Valve, which is designed to treat severe aortic valve stenosis without open-heart surgery or surgical removal of the native valve) 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-01253-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-11-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01253-1
  • 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 has received thirty-eight (38) reported nose cone separation events (.08 percent of implant procedures); five (5) of these reported events (.01 percent of implant procedures) led to the need for surgical intervention. a thorough review and investigation of the reported events has identified that a majority of these reported events occurred in situations cautioned against in current labelling. in addition, medtronic has determined that the following situations can lead to nose cone separations:-using the corevalve accutrak dcs to retrieve (remove) a partially deployed valve.- removing the corevalve accutrak dcs from the patient, after valve deployment, without fully closing the corevalve accutrak dcs capsule. -continuing to pull on the corevalve accutrak dcs if increased resistance is felt at the vessel introducer, the introducer’s hemostatic valve, or other structure during corevalve accutrak dcs retrieval.
  • 조치
    To reduce the occurrence of nose cone separations, Medtronic is modifying the instructions for use (IFU) and training materials for CoreValve AccuTrak DCS models DCS-C4-18Fr and DCS-C4-18Fr-23. Medtronic is advising that physicians implement the updated IFU recommendations to reduce occurrences of nose cone separation events during the CoreValve implant procedure.

Device

CoreValve AccuTrak Delivery Catheter System (DCS) (Intended to deliver CoreValve Transcatheter Ao...
  • 모델명 / 제조번호(시리얼번호)
    CoreValve AccuTrak Delivery Catheter System (DCS) (Intended to deliver CoreValve Transcatheter Aortic Valve, which is designed to treat severe aortic valve stenosis without open-heart surgery or surgical removal of the native valve)Models DCS-C4-18Fr and DCS-C4-18Fr-23Supplied in Australia under the Clinical Trial Notification (CTN) and Authorised Prescriber Schemes
  • 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