BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3236365 · Received July 16, 2013

    Report

    Report Number
    3236365
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    February 5, 2013
    Report Date
    July 16, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE SEWING DOWN THE AORTIC VALVE PROSTHESIS, THE DOCTOR NOTICED THAT THE SUTURE FROM THE FACTORY THAT HOLDS THE VALVE ON THE APPLYING APPARATUS WAS NOT REMOVED. DR REMOVED SUTURE AND CONTINUED WITHOUT ANY NEGATIVE OUTCOME. REP FROM EDWARDS LIFESCIENCES WAS NOTIFIED AND SAID SUTURE WAS PLACE IN A SPECIMEN CONTAINER. THE VALVE MODEL# IS 2700TFX, SIZE 23MM. THE MFR IS LOOKING INTO THE ISSUE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?AORTIC VALVE REPLACEMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330290 * REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 2700TFX *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR