Events

Safety Alert for Cardiac Valve Auto - Expandable Without Suture PERCEVAL S -

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Sorin Group Italia S.R.L.

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
    I1703-109
  • Event Number
    2014DM-0012018
  • Date
    2017-03-23
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=96
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that as a result of some cases of central or perioperative leakage, it is providing clarifications regarding the implantation instructions that will be integrated into the instructions for use (ifu) and will provide a guide that provides a detailed and illustrated description of the steps of preparing the valve and of implementation as support material, the foregoing as a preventive action to reduce the probability of presenting serious events about patients.

Device

Cardiac Valve Auto - Expandable Without Suture PERCEVAL S -
  • Model / Serial
  • Product Description
    PERCEVAL S is a bioprosthetic valve designed to replace a diseased native aortic valve or a prosthetic malfunction through open-heart surgery, with the unique feature of allowing positioning and anchoring in the implant site without suture.
  • Manufacturer
    Sorin Group Italia S.R.L

Manufacturer

Sorin Group Italia S.R.L