BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUALASE LASER GUIDED ABLATION SYSTEM

    MDR report key: 8575105 · Received May 2, 2019

    Report

    Report Number
    1723170-2019-02124
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    March 6, 2019
    Report Date
    May 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    UDI-DI
    00643169655935
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH: PATIENT AGE IS THE MEAN OF THE PATIENTS IN THE STUDY. SEX: PATIENT SEX NOT AVAILABLE FROM THE SITE. WEIGHT: PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. DEVICE EVALUATED BY MFR: NO ADDITIONAL INFORMATION HAS BEEN PROVIDED/SUBMITTED TO THE MANUFACTURER FOR AN EVALUATION TO BE CONDUCTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. - (B)(4).

    Description of Event or Problem · 1

    CITATION: CAJIGAS I, KANNER AM, RIBOT R, CASABELLA AM, MAHAVADI A, JERMAKOWICZ W, SUR S, MILLAN C, SAPORTA A, LOWE M, VELEZ-RUIZ N, REY G, IBRAHIM GM, IVAN ME, JAGID JR, "MRI-GUIDED LASER INTERSTITIAL THERMAL THERAPY FOR MESIAL TEMPORAL EPILEPSY: A CASE SERIES ANALYSIS OF OUTCOMES AND COMPLICATIONS AT TWO-YEAR FOLLOW-UP." WORLD NEUROSURGERY (2019), DOI: HTTPS://DOI.ORG/10.1016/J.WNEU.2019.03.057. SUMMARY: BACKGROUND: LASER INTERSTITIAL THERMAL THERAPY (LITT) PRESENTS AN IMPORTANT NEW MINIMALLY INVASIVE TOOL IN THE MANAGEMENT OF DRUG RESISTANT MESIAL TEMPORAL EPILEPSY (MTE). HOWEVER, BECAUSE OF ITS RELATIVE NOVELTY, NOT MUCH IS KNOWN ABOUT LONG-TERM SEIZURE FREEDOM RATES. OBJECTIVE: TO EVALUATE THE POST-SURGICAL SEIZURE OUTCOME FOLLOWING LITT AFTER A MINIMUM FOLLOW-UP PERIOD OF 2 YEARS. METHODS: MEDICAL RECORDS OF ALL PATIENTS WHO UNDERWENT LITT FOR MTE FROM 2013 TO 2018 AT OUR COMPREHENSIVE EPILEPSY CENTER UNDER A SINGLE SURGEON WERE RETROSPECTIVELY REVIEWED. DATA RELATED TO DEMOGRAPHICS, PRESURGICAL EVALUATIONS, AND SEIZURE OUTCOME WAS COMPARED BETWEEN SEIZURE FREE (SF) AND NON-10 SEIZURE-FREE (NSF) PATIENTS. RESULTS: 26 PATIENTS WERE IDENTIFIED WITH AT LEAST TWO YEARS OF FOLLOW-UP. MEAN AGE WAS 43.8 YEARS ± 11.6 AND 46.2% WERE FEMALE. AFTER A MEAN FOLLOW-UP TIME OF 42.9 MONTHS (RANGE 24.3 ¿ 58.8 MONTHS), 61.5% (16/26) WERE FREE OF DISABLING SEIZURES AND 26.9% (7/26) HAD ONLY RARE DISABLING SEIZURES. WHILE SEIZURE-FREEDOM RATES BETWEEN PATIENTS WITH AND WITHOUT MESIAL TEMPORAL SCLEROSIS (MTS) WERE NOT STATISTICALLY DIFFERENT (68% VS. 43%, P=.23), NSF PATIENTS WITHOUT MTS HAD A SHORTER MEDIAN TIME TO FIRST SEIZURE COMPARED TO NSF PATIENTS WITH MTS (0.55 MONTH VS. 10 MONTHS, LOG-RANK TEST P=0.007). POST-OPERATIVE COMPLICATIONS OCCURRED IN TWO PATIENTS (7.7%), CONSISTING OF ONE PERMANENT AND ONE TRANSIENT HOMONYMOUS HEMIANOPIA. CONCLUSION: LITT APPEARS TO BE A SAFE AND EFFECTIVE INITIAL SURGICAL OPTION FOR TREATMENT-RESISTANT MTE. AMONG PATIENTS THAT HAVE SEIZURES AFTER TREATMENT, THOSE WITHOUT MTS APPEAR TO HAVE SEIZURES EARLIER THAN THOSE WITH MTS. REPORTED EVENTS: ONE PERMANENT INSTANCE OF TRANSIENT HOMONYMOUS HEMIANOPIA; ONE TEMPORARY INSTANCE OF TRANSIENT HOMONYMOUS HEMIANOPIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368563 VISUALASE LASER GUIDED ABLATION SYSTEM LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC 9735542 00643169655935

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention