Events

Safety Alert for 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:

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by LIVANOVA CANADÁ CORP.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2026
  • Date
    2016-12-06
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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
  • Reason
    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.
  • Action
    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