Events

Alerta De Seguridad para Trade name: PERCEVAL HEART VALVE S. Technical name: HEART VALVE. ANVISA registration number: 80483300010. Risk class: IV - Maximum risk. Affected models: PVS21; PVS23; PVS25; PVS27. Serial numbers affected:

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por LIVANOVA CANADÁ CORP.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2026
  • Fecha
    2016-12-06
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    The company recommends reviewing the information provided in the accompanying document (IM-00760 "Key points of the Perceval implant"), considering all of the following: • Patient preoperative assessment • Out of the Jar Surgical technique - Aortotomy - Precautions related to the implant Perceval - Decalcification - Balloon - Inspection before closing aorta - Removal of guide sutures - Prosthesis removal procedure - Sizing - Guide sutures - Traction sutures - Valve placement
  • Causa
    Since the initial market introduction of the perceval valve, livanova has continued to obtain user feedback regarding critical procedural steps requiring careful execution to reduce the possibility of intraoperative complications such as poor valve positioning, significant perivalvular or central regurgitation, and implantation of permanent pacemaker. following some cases of intra-perioperative central leakage, livanova is providing clarification on the implantation steps to integrate the information covered in the instructions for use and the service guide.
  • Acción
    Field Action Code FSCA-HV-2016-001detailed under the responsibility of the company Alcard Ind Mecânica LTDA. Company issued Safety Alert about surgical implant technique.

Device

Trade name: PERCEVAL HEART VALVE S. Technical name: HEART VALVE. ANVISA registration number: 8048...

Manufacturer

LIVANOVA CANADÁ CORP