Events

Retiro De Equipo (Recall) de Resolute Integrity Zotarolimuseluting Coronary Stent

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 Medtronic Vascular, 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
    66532
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0154-2014
  • Fecha de inicio del evento
    2013-10-07
  • Fecha de publicación del evento
    2013-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122556
  • 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
    Coronary drug-eluting stent - Product Code NIQ
  • Causa
    A small number of units in lot number 0006573585 of the resolute integrity zotarolimus-eluting coronary sten system may contain a compliance chart incorrectly referencing a 2.25 mm diameter instead of the correct 3.0mm.
  • Acción
    Urgent Medical Device Recall Letters were sent on October 7, 2013 via UPS 3-day service.

Device

Resolute Integrity Zotarolimuseluting Coronary Stent
  • Modelo / Serial
    Model: RSINT30034UX;  Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Resolute Integrity Zotarolimus-eluting Coronary Stent: || Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. || Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. || Minneapolis, MN. || Indicated for improving coronary luminal diameters in patients.
  • Manufacturer
    Medtronic Vascular, Inc.

Manufacturer

Medtronic Vascular, Inc.
  • Dirección del fabricante
    Medtronic Vascular, Inc., 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA