Events

Retiro De Equipo (Recall) de Device Recall AFX Endovascular AAA System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Endologix.

¿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
    76112
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1047-2017
  • Fecha de inicio del evento
    2016-12-27
  • Fecha de publicación del evento
    2017-01-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152175
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, endovascular graft, aortic aneurysm treatment - Product Code MIH
  • Causa
    Endologix updated the instructions for use (ifu) and implemented modifications to the afx endovascular aaa system (afx system).
  • Acción
    On 6/2/15, a Dear Physician letter was sent to inform their customers of the 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The letter provided update reports of the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System). On January 2016, a Dear Physician letter was sent to customers to inform them of the 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The letter provided update reports of the cumulative clinical data and commercial experience (i.e., post-market surveillance) of the Powerlink System and the AFX Endovascular AAA system and contains important information and recommendations regarding the continued safe and effective use of these devices. On 12/27/16, a Dear Physician letter will be sent to customers to inform them of the important information related to the AFX Endovascular AAA System (AFX System). The letter provides a series of updates to the Instructions for Use (IFU) and modifications to the product were implemented, including introduction of a graft material processing improvement known as Duraply. Customer are informed of the on-going Endologix investigation that the changes may help prevent the occurrence of Type III endoleaks reported with the AFX device.

Device

Device Recall AFX Endovascular AAA System
  • Modelo / Serial
    The correction is not lot specific. It applies to AFX procedures conducted after October 2015
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    US and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
  • Descripción del producto
    AFX Endovascular AAA System, Endoleak Type IIIA || Product Usage: || The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
  • Manufacturer
    Endologix

Manufacturer

Endologix
  • Dirección del fabricante
    Endologix, 35 Hammond, Irvine CA 92618-1607
  • Empresa matriz del fabricante (2017)
    Endologix Inc.
  • Source
    USFDA