Events

TALENT LPS Standard Abdominal Range Aortic Endoprosthesis 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 MEDTRONIC 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
  • 날짜
    2001-10-15
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/endoprotheses-aortiques-talent-lps-societe-medtronic
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • 데이터 추가 비고
  • 조치
    The Director General of the French Agency for Health Safety of Health Products. Vu. books II and III of the fifth part of the code of public health and in particular article L. 5312-1. Vu. the Agency's letters of 27 December 1999 and 4 August 2000 requesting MEDTRONIC to provide information on the TALENT LPS Standard Abdominal Range Aortic Endoprosthesis. Vu. the report prepared by Afssaps' aortic stents working group. Vu. the meeting of 30 January 2001 at the French Agency for Health Safety of Health Products at which MEDTRONIC was able to present its observations on the conclusions of the work of the working group "aortic stents". Vu. Afssaps letter of 20 June 2001 to MEDTRONIC informing it of the intention to suspend the placing on the market and use of the TALENT LPS standard abdominal range endoprosthesis for the endovascular treatment of infrarenal abdominal aortic aneurysms. Vu. MEDTRONIC's replies dated July 6 and August 3, 2001. Seen. the meetings of 17 July and 24 September 2001. Recital. the pre-clinical and clinical data provided by the manufacturer do not provide sufficient assurance as to the efficacy and safety of the TALENT LPS stent. Considering. the existence of alternatives for the management of infrarenal abdominal aortic aneurysms. DECID. Article 1.. The marketing and use of the TALENT LPS standard abdominal range endoprosthesis is suspended. Article. . The Director of Medical Devices Evaluation and the Director of Inspection and Establishments are responsible, each for his own part, for the implementation of this decision, which will be published in the Official Journal. of the French Republic. Done at Paris on 15 October 2001

Device

TALENT LPS Standard Abdominal Range Aortic Endoprosthesis
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    MEDTRONIC

Manufacturer

MEDTRONIC
  • 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
    LAANSM