Events

Retiro De Equipo (Recall) de Evalve MitraClip

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Evalve 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
    19733
  • Fecha de inicio del evento
    2016-02-05
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Vascular Division of Abbott Laboratories (NZ) Ltd, Ground Floor, Building D, 4 Pacific Rise, Mount Wellington, Auckland 1060
  • Causa
    Manufacturer has recently received reports of cases in clip delivery system devices that contain the one-way actuator knob where a user attempted implanting a mitralclip but the clip could not be detached from the delivery system due to a mandrel fracture. these cases resulted in severe surgical interventions and in one case the patient died post-operatively due to severe comorbidities., current instructions for use (ifu) require the arm positioner to be in a neutral position prior to turning the actuator knob to deploy the clip; manufacturerr is revising the mitraclip ifu clip deployment sequence to provide additional assurance that tension is completely eliminated prior to deploying the clip. abbott vascular will train all mitraclip implanters on the revised instructions., note : currently, there are no mitraclip systems in new zealand.
  • Acción
    Manufacturer to issue advice regarding use

Device

Evalve MitraClip

Manufacturer

Evalve Inc
  • 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
    NZMMDSA