Events

Zenith Alpha™ 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Cook Medical Europe 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2017-03-22
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    With this safety announcement, we would like to remind you of several aspects of the new version of the instruction manual (nzu) for thoracic endovascular insertion of zenith alpha ™. these updates are crucial in the use of the thoracic aortic thoracic aortic disorder (tpta) device, which is now covered by the newly approved indication for individual lesions of a descending thoracic aorta. the security notice is for informational purposes only. no devices need to be returned, and patients already treated for tpta should be monitored in accordance with current nzus, as follow-up has not been altered. in a clinical trial evaluating the use of a tpta device (without occlusion, adverse clinical consequences, or the need for open surgery / bypass), an incidental thrombus was inserted in the insert during ongoing monitoring in approximately 25% of patients. the literature cites incidence insertion thrombus (including tpta treatment) in the range of 15–40% .1,2,3,4,5 occurrence of insertion occlusion (requiring open surgery / bypass) were also detected after endovascular treatment for tpta.

Device

Zenith Alpha™

Manufacturer

Cook Medical Europe