BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAMBDA PLUS PDL FOR PDT

    MDR report key: 129541 · Received October 29, 1997

    Report

    Report Number
    2914019-1997-00031
    Event Type
    Death
    Date Received
    October 29, 1997
    Date of Event
    September 27, 1997
    Report Date
    October 2, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN CONCLUSION, THE FOLLOWING INFO IS PROVIDED: HOSPITAL AND MEDICAL CENTER DISCHARGE SUMMARY BY DR: IN DR'S DISCHARGE SUMMARY HE STATES,"...ALTHOUGH NO ABSOLUTE CONCLUSIONS HAVE BEEN PROVED TO EXPLAIN THIS INCIDENT, THE CONSENSUS AMONGST THE INVOLVED DISCIPLINES WAS THAT THIS PT HAD A HYPERCOAGULABLE STATE AT THE TIME PDT TREATMENT PREDISPOSING HER TO THE EXTENSIVE HEMORRHAGIC NECROSIS DESCRIBED. OVER THE PAST MONTH THE PHOTODYNAMIC THERAPY LAB HAS RESUMED FULL FUNCTION WITHOUT INCIDENT." POSTMARKETING SUSPECT ADVERSE REACTION REPORT: ACTION TAKEN IN SUMMARY: THE INSTITUTION HAS CHANGED THE TREATMENT PROTOCOL THEY USE TO REDUCE THE DOSAGE OF LIGHT FROM 300J/CM TO 200J/CM AND TO SPECIFY THAT THE MAXIMUM LENGTH OF BARRETT'S ESOPHAGUS TREATED IN ONE SESSION NOT EXCEED 7 CM. THE LIGHT DOSE OF 300J/CM WAS THE RECOMMENDED DOSE FOR THE TREATMENT OF OBSTRUCTIVE ADVANCED ESOPHAGEAL CANCER AND HAS BEEN USED BEFORE IN THIS INDICATION. RECENT UNPUBLISHED CLINICAL EXPERIENCE INDICATES THAT TREATING LARGER SEGMENTS MAY BE ASSOCIATED WITH HIGHER SYSTEMIC TOXICITY. PHOTODYNAMIC THERAPY IS A 2-STEP PROCEDURE INVOLVING BOTH THE INJECTION OF PHOTOSENSITIZER (PHOTOFRIN) AND ILLUMINATION WITH APPROPRIATE LIGHT DELIVERY DEVICES. QLT PHOTOTHERAPUETICS HOLD THE NDA FOR PHOTOFRIN (NDA# 20-451) AND THE PMA FOR THE FIBER OPTIC DIFFUSERS, OPTIGUIDE. COHERENT MEDICAL GROUP HOLD THE PMA FOR THE LASERS THAT PROVIDES THE LIGHT ILLUMINATION SOURCE, LAMBDA PDL1 AND PDL2.

    Description of Event or Problem · 1

    PHOTODYNAMIC THERAPY (PDT) WAS USED FOR CARCINOMA OF ESOPHAGUS. PT RECEIVED INJECTION OF PHOTOFRIN ON 9/22/97 FOR THE TREATMENT AND THEN WAS ADMINISTERED TWO LIGHT DELIVERIES, ONE ON 9/24/97 AND THE OTHER ON 9/25/97. PT DIED ON 9/27/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMBDA PLUS PDL FOR PDT SURGICAL LASER GEX COHERENT MEDICAL LASER GROUP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death