Events

Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 LivaNova Australia 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-01197-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-10-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01197-1
  • 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
    Following some cases (55 out of 16048 devices sold) of intra/peri-operative central leak, livanova is providing clarifications about the implant techniques for the perceval sutureless aortic heart valve and bringing to the attention of users some steps that may influence procedural success and potential complications. this information is being provided in the document im-00763 perceval implant key points and will subsequently be integrated into upcoming revisions of the instructions for use (ifu) and the inservice guide training material.
  • 조치
    LivaNova is providing users with information that clarifies implantation steps, in the form of the document IM-00763 Perceval Implant Key Points. Upcoming revisions of the IFU and InService Guide will incorporate this information. This action has been closed-out on 16/02/2017.

Device

Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)
  • 모델명 / 제조번호(시리얼번호)
    Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)Perceval Sutureless Heart Valve size SItem Number: ICV1208Reference: PVS21Perceval Sutureless Heart Valve size MItem Number: ICV1209Reference: PVS23Perceval Sutureless Heart Valve size LItem Number: ICV1210Reference: PVS25Perceval Sutureless Heart Valve size XLItem Number: ICV1211Reference: PVS27ARTG Number: 232485
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd