Events

Field Safety Notices about Perceval Sutureless Heart Valve

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Sorin Group Italia S.r.l..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-08-26
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.