Events

Retiro De Equipo (Recall) de Nellix EndoVascular Aneurysm Sealing 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 AA-Med 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-01228-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-01-11
  • 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-01228-1
  • 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
    Endologix is providing an update to the recall for product correction issued in october 2016 for the nellix system, and includes the current data available to support the refined ifu and patient selection criteria, options for secondary interventions in patients who have specific nellix related complications, and information related to off-label use of the nellix system.
  • Acción
    Physicians are notified that all patients require life-long, regular follow-up to assess the performance of their endovascular implant. Patients with specific clinical findings (eg, changes in the structure or position of the endovascular implant, endoleaks, or enlarging aneurysms) should receive enhanced clinical and imaging follow-up. Specifically, patients should receive a contrast enhanced CT scan. If renal complications or other factors preclude the use of image contrast medium, abdominal radiographs & duplex ultrasound may provide similar information. All asymptomatic patients should continue on annual follow-up, and this is particularly important for those who would now be considered off-label according to the refined IFU. Additional secondary endovascular interventions (see below) or conversion to standard open surgical repair should be considered for patients continuing to experience migration, significant endoleaks, and/or enlarging aneurysms during post-operative follow up.

Device

Nellix EndoVascular Aneurysm Sealing System
  • Modelo / Serial
    Nellix EndoVascular Aneurysm Sealing SystemARTG Number: 271833
  • Manufacturer
    AA-Med Pty Ltd

Manufacturer

AA-Med Pty Ltd
  • Source
    DHTGA