Events

Alerte De Sécurité sur 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:

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par LIVANOVA CANADÁ CORP.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2026
  • Date
    2016-12-06
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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
  • Cause
    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