Events

Retiro De Equipo (Recall) de HeartMate 3 Left Ventricular Assist 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 Abbott.

¿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
    79893
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1774-2018
  • Fecha de inicio del evento
    2018-04-05
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163823
  • 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
    Ventricular (assist) bypass - Product Code DSQ
  • Causa
    Reports of outflow graft twist occlusions. patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.
  • Acción
    Customers were notified via an Important Medical Device Advisory letter, dated 04/05/2018, that the firm has received reports of outflow graft twist occlusions in the HeartMate 3 (HM3) Left Ventricular Assist System. As a result, patients whose devices experience this issue will experience a persistent low flow alarm. Outflow graft twist occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death. Physicians managing patients that will be implanted or already implanted with HM3 devices should follow the recommendations provided in the letter. Additionally, physicians managing patients that exhibit a persistent low flow alarm should determine patient care recommendations based on each unique clinical case. Questions should be directed to customers' local Abbott MCS Clinical Specialist or MCS HeartLine 1-800-456-1477.

Device

HeartMate 3 Left Ventricular Assist System
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- U.S., including the states of MN, PA, IL, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, OH, NY, GA, VA, FL, OK, MD, ME, SC, IN, LA, OR, WA, AL, CO, IA, KS, KY, UT, DC, and CT; and, the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, Cayman Islands, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Kuwait, Lebanon, Malaysia, Montenegro, Netherlands, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 || Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • Dirección del fabricante
    Abbott, 6035 Stoneridge Dr, Pleasanton CA 94588-3270
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA