Events

Retiro De Equipo (Recall) de Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por LivaNova Australia Pty Ltd.

¿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
    RC-2016-RN-01197-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-10-18
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01197-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Following some cases (55 out of 16048 devices sold) of intra/peri-operative central leak, livanova is providing clarifications about the implant techniques for the perceval sutureless aortic heart valve and bringing to the attention of users some steps that may influence procedural success and potential complications. this information is being provided in the document im-00763 perceval implant key points and will subsequently be integrated into upcoming revisions of the instructions for use (ifu) and the inservice guide training material.
  • Acción
    LivaNova is providing users with information that clarifies implantation steps, in the form of the document IM-00763 Perceval Implant Key Points. Upcoming revisions of the IFU and InService Guide will incorporate this information. This action has been closed-out on 16/02/2017.

Device

Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)
  • Modelo / Serial
    Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)Perceval Sutureless Heart Valve size SItem Number: ICV1208Reference: PVS21Perceval Sutureless Heart Valve size MItem Number: ICV1209Reference: PVS23Perceval Sutureless Heart Valve size LItem Number: ICV1210Reference: PVS25Perceval Sutureless Heart Valve size XLItem Number: ICV1211Reference: PVS27ARTG Number: 232485
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd