Events

Alerta De Seguridad para IMPLANT FOR ANEURISMA MATRIX - Model MATRIX2 Standard 2D SR 8mm x 30cm. Anvisa Registry: 10341350546.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Boston Scientific Corp.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1035
  • Fecha
    2010-11-18
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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%).
  • Causa
    Premature degradation of the pgla (polyglycolic-polylactic acid) suture, before expiration of the shelf-life of the product.
  • Acción
    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
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “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