Perceval Sutureless Heart Valve 에 대한 현장 안전성 서한

Field Safety Notice

2016-08-26

Slovenia

AMPMDRS

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. .