Events

Retiro De Equipo (Recall) de Lotus Valve System Material Description: LOTUS TAVR 23mm, H749LTV230

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-2017-RN-00291-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-02-24
  • 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-2017-RN-00291-1
  • 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
    Boston scientific has received higher than anticipated number of reports of early pin release prior to locking the valve in the final position. if this occurs, the valve is unable to be fully locked, which requires the valve to be re-sheathed and removed from the patient prolonging the procedure. removal of the valve was successful in all but one case where the valve embolised and was secured in the descending aorta. all patients were successfully treated with another valve, except for one reported case where the affected valve was removed, but an aortic dissection occurred during implantation of the second valve whereby the patient subsequently died.Please note that there are no safety concerns for patients who have previously received a lotus valve and the issue does not impact the performance of the implanted valve. it is only a potential issue during the implant procedure itself.
  • Acción
    Boston Scientific (BSC) is advising users to immediately discontinue use of and segregate affected products. Users are further advised to immediately remove all affected products from their inventory and quarantine the affected stock in a secure location prior to their return to BSC.

Device

Lotus Valve System Material Description: LOTUS TAVR 23mm, H749LTV230
  • Modelo / Serial
    Lotus Valve System Material Description: LOTUS TAVR 23mm, H749LTV230Batch Number: 19634742Material Description: LOTUS TAVR 25mm, H749LTV250Batch Number: 19520317, 19696773,19520319 and 19696774 Material Description: LOTUS TAVR 27mm, H749LTV270Batch Number: 19686549 and 19978598 ARTG Number: 260448
  • Clasificación del producto
    Cardiovascular Devices
  • 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