Events

Retiro De Equipo (Recall) de PROMUS Element Plus MONORAIL Everolimus-Eluting Coronary Stent System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Boston Scientific Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-00713-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-07-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00713-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    Units of the promus element plus monorail everolimus-eluting coronary stent system has been supplied without the appropriate australian directions for use (dfu) ie, the appropriate content of the pre- and post- procedure anti-platelet regimen is not included in the dfu.
  • Acción
    Boston Scientific is undertaking a recall for product correction to provide a copy of the correct DFU for end users to follow. Surgeons who have implanted an affected batch of the device are being provided with a Hazard Alert letter with the information on the correct post-procedure anti-platelet regimen.

Device

PROMUS Element Plus MONORAIL Everolimus-Eluting Coronary Stent System
  • Modelo / Serial
    PROMUS Element Plus MONORAIL Everolimus-Eluting Coronary Stent SystemMultiple lot numbers affectedARTG Number: 200539
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • 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
    DHTGA