Events

Mosaic Porcine Aortic Bioprosthesis Model 305 and Medtronic Aortic Obturators/Sizers and iOEA Charts Hazard Alert - MosaicPorcine Aortic Bioprosthesis Model 305 All sizes and configurations ie, Standard and Ultra Recall - Medtronic Aortic Obturators/Sizers and iOEA -indexed Effective Orifice Area Charts 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-2014-RN-00015-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-01-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00015-1
  • 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
    The current mosaic aortic bioprosthesis sizing chart and obturators/sizers may contribute in some cases to the selection of a larger than optimal mosaic aortic bioprosthesis. medtronic has determined that the practice of substantial oversizing can lead to the reported cases of higher-than-expected transvalvular gradients post implantation. specifically, considerable oversizing, or implanting a valve substantially larger than the native aortic annulus, may result in the alteration of normal leaflet movement as blood flowing through the native annulus may not properly match the size and/or shape of the inflow of the mosaic aortic bioprosthesis. the higher-than-expected transvalvular gradients (> 25 mmhg) have occurred at a rate of 0.33 percent (3.3 reports per 1000 aortic implants). a subset of these valves were explanted within five years of implantation at an overall occurrence rate of 0.1 percent (1 explant per 1000 aortic implants).
  • 조치
    Medtronic is not making any specific patient management recommendations for the patients implanted with the Medtronic Mosaic Aortic Bioprosthesis. Surgeons and cardiologists should continue to follow their patients per their usual practice and in accordance with published guidelines. Medtronic has updated the iEOA Mosaic Aortic Bioprosthesis sizing chart and also, modified the current Mosaic Obturators/Sizers to align with the updated sizing chart. The IFU for the modified Mosaic Obturators/Sizers has been updated to include the new sizing chart (iEOA chart). Medtronic recommends surgeons continue to remain diligent in selecting the appropriate size of Mosaic Aortic Bioprosthesis. Adoption of the updated Mosaic Aortic Bioprosthesis sizing chart (iEOA chart) and Mosaic Obturators/Sizers will facilitate optimal aortic valve size selection. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-bioprosthesis-140128.htm .

Device

Mosaic Porcine Aortic Bioprosthesis Model 305 and Medtronic Aortic Obturators/Sizers and iOEA Cha...
  • 모델명 / 제조번호(시리얼번호)
    Mosaic Porcine Aortic Bioprosthesis Model 305 and Medtronic Aortic Obturators/Sizers and iOEA Charts Hazard Alert - MosaicPorcine Aortic Bioprosthesis Model 305 All sizes and configurations ie, Standard and UltraARTG 145761Recall - Medtronic Aortic Obturators/Sizers and iOEA -indexed Effective Orifice Area Charts Model Numbers: 7305, 7305OD, 7305UXARTG 98977
  • 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