BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX 4

    MDR report key: 383075 · Received March 16, 2002

    Report

    Report Number
    3003468702-2002-00001
    Event Type
    Injury
    Date Received
    March 16, 2002
    Date of Event
    January 31, 2002
    Report Date
    March 15, 2002
    Manufacturer
    AFX INC.
    Product Code
    NEY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 10/2001 A PT RECEIVED A MITRAL VALVE REPLACEMENT PROCEDURE CONCOMITANT TO AN ABLATION PROCEDURE. LESIONS WERE CREATED ON THE POSTERIOR AND LATERAL LEFT ATRIUM. THREE MONTHS FOLLOWING THE INITIAL SURGERY THE PT PRESENTED WITH STENOSIS OF THE MAIN STEM AND REQUIRED A BYPASS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX 4 SURGICAL ABLATION TOOL NEY AFX INC. 102006-02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention| S MITRAL VALVE REPLACEMENT.