Events

IMPLANT FOR ANEURISMA MATRIX - Model MATRIX2 Standard 2D SR 8mm x 30cm. Anvisa Registry: 10341350546. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Boston Scientific Corp 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1035
  • 날짜
    2010-11-18
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    According to the product registration holder in Brazil, during the product implantation procedure there is a risk of foreign body embolization due to the release of the PGLA coating, which could lead to a stroke in the patient (in a more critical scenario) . PGLA is a bioactive polymer that covers the product's platinum spring and, according to Boston Scientific's risk assessment, the increased risk of its detachment (and consequent embolization) is limited to the surgical procedure. 05/2011): Boston Scientific do Brasil Ltda closed the field action on the Matrix product in January 2011, according to a letter sent to UTVIG (file: 083134 / 11-4). According to the company, 13 units of the product were collected in the Brazilian market, out of a total of 1429 units (0.9%).
  • 원인
    Premature degradation of the pgla (polyglycolic-polylactic acid) suture, before expiration of the shelf-life of the product.
  • 조치
    Recommended actions to professionals / users / patients of the product: (1) cease use of the product immediately; (2) Segregate the affected units, identifying them so that they are not used inadvertently; (3) Return the product to the record holder (Boston Scientific do Brasil Ltda); and (4) in the case of distributors, notify the customers who own the affected products. The company Boston Ltda has already started collecting the product.

Device

IMPLANT FOR ANEURISMA MATRIX - Model MATRIX2 Standard 2D SR 8mm x 30cm. Anvisa Registry: 10341350...

Manufacturer

Boston Scientific Corp
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    ANVSANVISA