Events

Notificaciones De Seguridad De Campo acerca de Perceval Sutureless Heart Valve

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Sorin Group Italia S.r.l..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-08-26
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Perceval is a bioprosthetic valve designed to replace a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery, with the unique characteristic of allowing sutureless positioning and anchoring at the implant site. the prosthesis is indicated for use in adult patients who are diagnosed to have aortic valve stenosis or steno-insufficiency. being an innovative device whose implant technique differs from that of the most common sutured aortic valve prostheses, perceval implantation shall be performed only by physician and associated staff trained in the specific steps for preparation and implantation by successful completion of our dedicated proctoring program for perceval. in addition to the instructions for use accompanying each device, an “inservice guide” with a detailed and illustrated description of the valve preparation and implantation steps is provided as training material. since initial market introduction of the perceval valve, livanova has continued to gather feedback from users regarding critical procedural steps requiring careful execution in order to reduce the possibility of intraoperative complications, such as valve malpositioning, significant perivalvular or central regurgitation and permanent pacemaker implantation. following some cases of intra/peri-operative central leak, livanova is providing clarifications on the implantations steps in order to integrate information addressed in the instructions for use and the inservice guide. .

Device

Perceval Sutureless Heart Valve

Manufacturer

Sorin Group Italia S.r.l.