BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVLT LASER AND KIT

    MDR report key: 938210 · Received November 5, 2007

    Report

    Report Number
    9617149-2007-00004
    Event Type
    Death
    Date Received
    November 5, 2007
    Date of Event
    September 26, 2007
    Report Date
    October 3, 2007
    Manufacturer
    DIOMED, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K012398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INDICATIONS ARE THE EVLT KIT AND/OR LASER PERFORMED IN ACCORDANCE WITH MFR'S SPECIFICATION. ULTRASOUND IMMEDIATELY POST EVLT INDICATED THE PROCEDURE WENT AS EXPECTED WITH NO COMPLICATIONS. THIS REPORT IS BASED ON INFO PROVIDED BY THE REPORTING PHYSICIAN WHOSE INVOLVEMENT WAS LIMITED TO THE TREATMENT OF THE PATIENT FOR VARICOSE VEINS AND ATTEMPTED FOLLOW-UP FOR THE 2007 PROCEDURES. THE PHYSICIAN COULD NOT IDENTIFY THE HOSPITAL WHERE THE PATIENT WAS TAKEN FOR THE REPORTED EVENT OR ANY PHYSICIAN WHO MAY HAVE ASSESSED THE PATIENT. THE COMPANY DOES NOT HAVE ACCESS TO THE PATIENT'S MEDICAL RECORDS OR ANY CERTIFICATE OF DEATH. BASED UPON THE COMPANY'S INVESTIGATION, THERE IS NO INDICATION OF A CAUSAL LINK BETWEEN THE EVLT PROCEDURE AND THE REPORTED EVENT. ON OCT 24, 2007, A FIELD SERVICE CALIBRATION EVALUATION WAS CONDUCTED. THE LASER PASSED OPERATOR FUNCTIONAL TESTING. THE CALIBRATION WAS WITHIN ACCEPTABLE TOLERANCES AND MET SPECIFICATION. POWER, IN WATTS, WAS MEASURED UTILIZING A CALIBRATED POWER METER AND WAS FOUND TO MEET SPECIFICATIONS AT THE FIBER TIP USING A DIOMED FIBER. THE LASER WAS RETURNED TO DIOMED FOR FURTHER EVALUATION AND WAS RECEIVED OCT 31, 2007. ON NOV 1, THE LASER SESSION STATISTICS DATA LOG WAS PRINTED AND EXAMINED BY THE SERVICE DEPT. THE RESULTS FOR THE SESSION DATES WHEN THE PATIENT ALLEGEDLY WAS TREATED, MET PERFORMANCE SPECIFICATION. THE RESULTS FOR THE DATE OF QUESTION REVEALED OUTPUT WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IN 2007, A WOMAN HAD HER GREAT SAPHENOUS VEIN, THE SMALL SAPHENOUS VEIN AND THE HUNTERIAN PERFORATOR TREATED WITH EVLT. SUPERFICIAL VEINS WERE TREATED, POST EVLT, WITH FOAM SCLEROTHERAPY USING POLIDOCANOL AND THE SCLEROSANT. POST EVLT ULTRASOUND DEMONSTRATED CLOSURE OF THE VEINS WITH GOOD RESULTS. SHE HAD AN ACE BANDAGE AND COMPRESSION STOCKING APPLIED AND WAS DISCHARGED TO HOME. THE PATIENT DID NOT RESPOND TO A TELEPHONE FOLLOW-UP CALL BY THE PHYSICIAN'S OFFICE OR SCHEDULE A FOLLOW UP VISIT. ACCORDING TO THE INITIAL REPORTER, SIX DAYS POST EVLT, THE WOMAN COLLAPSED AT HER WORKPLACE, AND FOUND SLUMPED ON HER DESK AND UNRESPONSIVE. SHE WAS TRANSPORTED, CPR IN PROGRESS, TO AN EMERGENCY ROOM ARRIVING PULSELESS. EFFORTS TO REVIVE HER WERE NOT SUCCESSFUL AND SHE DIED SOMETIME AFTER ARRIVING. THERE ARE NO DETAILS, AT THIS TIME, OF TREATMENT RECEIVED AT THE EMERGENCY ROOM. THERE WAS NO AUTOPSY PERFORMED. THERE IS NO INDICATION OF A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE EVLT KIT. THE REPORTING PHYSICIAN SPOKE TO THE PATIENT'S HUSBAND WHO REPORTED THAT A PHYSICIAN AT THE HOSPITAL HAD INDICATED A POSSIBLE PULMONARY EMBOLISM HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVLT LASER AND KIT ENDOVENOUS LASER TREATMENT KIT GEX DIOMED, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death