Events

Retiro De Equipo (Recall) de Device Recall Ovation Prime Abdominal Stent Graft 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 Trivascular, Inc.

¿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
    67672
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1297-2014
  • Fecha de inicio del evento
    2014-02-27
  • Fecha de publicación del evento
    2014-03-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126008
  • 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
    Communication to european physician users of the ovation prime abdominal stent graft system to notify them of changes to instructions for use.
  • Acción
    Trivascular sent an Important Medical Device Information letter dated February 27, 2014, to all European physicians who have scheduled cases through March 31, 2014 or until IFU;s are translated and available for European physicians. The letter provided notification of an update that will appear in a future revision of the product Instructions for Use (IFU). The IFU will be available in their country when the required translations and product registration/notification have been completed. This IFU does not require rework or return of the affected product. Customers with questions were instructed to contact their local TriVascular representative. For questions regarding this recall call 707-543-8805.

Device

Device Recall Ovation Prime Abdominal Stent Graft System
  • Modelo / Serial
    All codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution including Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Norway, Poland, Spain, and Sweden.
  • Descripción del producto
    Ovation Prime Abdominal Stent Graft System; || Manufacturer: || TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 || The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.
  • Manufacturer
    Trivascular, Inc

Manufacturer

Trivascular, Inc
  • Dirección del fabricante
    Trivascular, Inc, 3910 Brickway Blvd, Santa Rosa CA 95403
  • Empresa matriz del fabricante (2017)
    Endologix Inc.
  • Source
    USFDA