BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUALASE

    MDR report key: 11046143 · Received December 21, 2020

    Report

    Report Number
    1723170-2020-03352
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    May 1, 2014
    Report Date
    December 21, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE NOT AVAILABLE FROM THE SITE. PATIENT SEX NOT AVAILABLE FROM THE SITE. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE PUBLICATION DATE OF THE ABSTRACT. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: DANIEL CURRY, ANIL SHETTY, ANGUS A. WILFONG. OUTCOMES OF STEREOTACTIC LASER ABLATION FOR TREATMENT-RESISTANT EPILEPSY IN THE PEDIATRIC POPULATION WITH 1 YEAR FOLLOW-UP. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY (2014) 92 SUPPL. 1 (11). DATE OF PUBLICATION: MAY 2014 ABSTRACT: INTRODUCTION: APPROXIMATELY 7600 NEW CASES OF PEDIATRIC EPILEPSY OCCUR EACH YEAR AND IT IS ESTIMATED THAT AT LEAST ONE-THIRD OF THEM WITH BE REFRACTORY TO MEDICAL MANAGEMENT. PEDIATRIC EPILEPSY SURGERY IS VASTLY UNDERUTILIZED (~400 /YEAR) DUE TO ITS INVASIVENESS AND MORBIDITY. STEREOTACTIC LASER ABLATION (SLA) IS A MINIMALLY INVASIVE ALTERNATIVE FOR SURGICAL CANDIDATES. WE PRESENT THE SAFETY AND PATIENT OUTCOMES IN TWENTY PATIENTS. METHODS: TWENTY PATIENTS WITH MEDICALLY INTRACTABLE LESIONAL EPILEPSY, AGES 2-18, UNDERWENT AN IRB-APPROVED FOCUS ABLATION. EPILEPTIC FOCI HAD VARIED ETIOLOGIES (HH:12,FCDS:4,MTS:3,TS:1). AN FDA-CLEARED SURGICAL LASER ABLATION SYSTEM (VISUALASE THERMAL THERAPY SYSTEM; VISUALASE, INC., HOUSTON, TX) WAS EMPLOYED IN THIS WORK. THE COOLED LASER APPLICATOR (1.6 MM IN DIAMETER) INCLUDES A FIBEROPTIC APPLICATOR WITH EITHER A 1 CM OR A 3 MM LIGHTDIFFUSING TIP. FRAMED STEREOTAXY WAS USED TO TARGET THE LESION AND MR THERMOGRAPHY WAS UTILIZED. AFTER A TEST DOSE OF 3-4 W CONFIRMED APPLICATOR POSITION, DOSES OF 5-12 W FOR 45-120 SECONDS WERE USED TO ABLATE THE FOCI. SAFETY LIMITS (50°C) WERE PLACED NEAR THE MARGIN OF THE DESIRED THERMAL ABLATION ZONE TO PROTECT CRITICAL STRUCTURE. POSTABLATION DWI, T1-WEIGHTED PLUS GADOLINIUM CONTRAST (T1 + GD), AND FFE SERIES WERE ACQUIRED. FOLLOW-UP PERIOD WAS FROM 11-41 MONTHS. RESULTS: 13 PATIENTS WERE SEIZURE FREE AFTER ONE ABLATION, 3 AFTER A SECOND PROCEDURE. IN THE 19 PTS WITH > 1 YEAR FOLLOW-UP, 11 ACHIEVED ENGEL 1 STATUS. 6 PATIENTS UNDERWENT REPEAT PROCEDURES, THREE ABLATIONS AND THREE CRANIOTOMIES. COMPLICATIONS INCLUDED 3 TRANSIENT SHORT TERM MEMORY DYSFUNCTIONS, ONE SUB-CLINICAL SUBARACHNOID HEMORRHAGE, AND ONE CSF LEAK. AVERAGE LOS WAS 1 DAY. CONCLUSIONS: STEREOTACTIC LASER ABLATION (SLA) FOR EPILEPTIC FOCI HAS DEMONSTRATED RATES OF SEIZURE FREEDOM THAT MATCH / ARE COMPARABLE TO OPEN SURGICAL RESULTS. LOW MORBIDITY, REDUCED LOS AND ABILITY TO STAGE PROCEDURES, ALONG WITH THE SAFETY OF REAL-TIME MR GUIDED ABLATION ARE ADVANTAGES. REPORTED EVENTS: -THREE PATIENTS EXPERIENCED TRANSIENT SHORT TERM MEMORY DYSFUNCTIONS. -ONE PATIENT EXPERIENCED A SUB-CLINICAL SUBARACHNOID HEMORRHAGE. -ONE CEREBROSPINAL FLUID (CSF) LEAK OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514694 VISUALASE LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC 9735542

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention