Events

Retiro De Equipo (Recall) de TriVascular Fill Polymer Kit

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
    63586
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0288-2013
  • Fecha de inicio del evento
    2012-10-19
  • Fecha de publicación del evento
    2012-11-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114263
  • 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
    Selected lots of the fill polymer kit (european model number: tvfp14- b) in european distributor inventory only that potentially contain leaking stopcocks due to possible cracks in the stopcock component. trivascular indicated that these fill polymer kits are for use with the ovation or ovation prime abdominal stent graft systems that may display leaks upon initiation of mix but prior to use in.
  • Acción
    Trivascular sent an Urgent Field Safety Notice letter dated October 19, 2012 to all affect consignees. A verbal (telephone) communication was also initiated. The forms communication identified the affected product, problem and actions to be taken. Consignees were instructed to immediately quarantine and return affected products. A return response form was included for consignees to complete and returned via the e-mail address or fax number provided. Consignees were instructed to further notify its (sub-level) consignees, and have them return affected product directly to the recalling firm. For questions call 1-707-543-8732.

Device

TriVascular Fill Polymer Kit
  • Modelo / Serial
    The following lot numbers are in distributor inventory in Europe: FF121211-04, FF010912-01, FF013112-01, FF020912-01, FF022212-03, FF022912-01, FF040412-01,  FF051012-01
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Belgium, Cyprus, Italy, Spain, Switzerland and Turkey. TriVascular stated that no purchased devices are in hospital inventory in Europe or the U.S.
  • Descripción del producto
    TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); || PRODUCT Usage: || The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular morphology suitable for endovascular repair, including: (1) Adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories, (2) Non-aneurysmal proximal aortic neck: - with a length of at least 7 mm proximal to the aneurysm, - with an inner wall diameter of no less than 16 mm and no greater than 30 mm, and - with an aortic angle of d 60 degrees if proximal neck is e 10 mm and d 45 degrees if proximal neck is < 10 mm, (3) Non-aneurysmal distal iliac landing zone: - with a length of at least 10 mm, - with an inner wall diameter of no less than 8 mm and no greater than 20 mm
  • 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