BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUALASE

    MDR report key: 8595298 · Received May 9, 2019

    Report

    Report Number
    1723170-2019-02244
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    August 15, 2018
    Report Date
    May 9, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: PATIENT IDENTIFIER WAS NOT INCLUDED IN THE JOURNAL ARTICLE. WEIGHT: PATIENT WEIGHT NOT INCLUDED IN THE JOURNAL ARTICLE. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE PUBLISHED ONLINE DATE AS THE EVENT DATE WAS NOT PROVIDED IN THE JOURNAL ARTICLE. DESCRIPTION OF PROBLEM OR EVENT: ARTICLE CITATION IS INCLUDED. SERIAL #, UDI #: SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. DEVICE EVALUATED BY MFR: NO EVALUATION WAS PERFORMED AS THIS EVENT WAS REPORTED IN LITERATURE. MANUFACTURE DATE: DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: FAYED I, SACINO M, F, GAILLARD W, D, KEATING R, F, OLUIGBO C, O: "MR-GUIDED LASER INTERSTITIAL THERMAL THERAPY FOR MEDICALLY REFRACTORY LESIONAL EPILEPSY IN PEDIATRIC PATIENTS: EXPERIENCE AND OUTCOMES." PEDIATR NEUROSURG 2018; 53: 322-329. DOI: 10.1159/000491823. SUMMARY: INTRODUCTION: MR-GUIDED LASER INTERSTITIAL THERMAL THERAPY (MRGLITT) HAS EMERGED AS A SAFE AND EFFECTIVE TREATMENT OPTION FOR THE ABLATION OF EPILEPTIC FOCI. ITS MINIMALLY INVASIVE NATURE MAKES IT ATTRACTIVE DUE TO DECREASED MORBIDITY AND HOSPITAL STAY. OBJECTIVE: TO REPORT THE EFFICACY AND SAFETY OF MRGLITT AS A MINIMALLY INVASIVE PROCEDURE FOR THE ABLATION OF EPILEPTIC FOCI IN THE PEDIATRIC POPULATION OF MEDICALLY REFRACTORY LESIONAL EPILEPSY. METHODS: A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT MRGLITT VIA VISUALASE LASER ABLATION AT A SINGLE PEDIATRIC CENTER WAS PERFORMED. DEMOGRAPHIC AND OUTCOME DATA WERE COMPILED AND ANALYZED. RESULTS: TWELVE PEDIATRIC PATIENTS WITH A TOTAL 18 LESIONS UNDERWENT MRGLITT PROCEDURES BETWEEN DECEMBER 2013 AND SEPTEMBER 2017. MEAN AGE AT SURGERY WAS 11.1 YEARS. SURGICAL SUBSTRATES INCLUDED 4 HYPOTHALAMIC HAMARTOMAS, 3 PERIVENTRICULAR HETEROTOPIAS, 2 DEEP FOCAL CORTICAL DYSPLASIAS, 2 TUBEROUS SCLEROSIS, AND 1 MESIAL TEMPORAL SCLEROSIS. METHODS OF STEREOTAXIS USED INCLUDED LEKSELL FRAME, BRAINLAB VARIOGUIDE, ROSA ROBOT GUIDANCE, AND CLEARPOINT NAVIGATION. MEAN PROCEDURE LENGTH WAS 250 MIN, AND MEAN LENGTH OF STAY WAS 1.3 DAYS. AFTER TREATMENT, 8 PATIENTS WERE SEIZURE FREE (ENGEL I, 66.7%), 2 PATIENTS DEMONSTRATED SIGNIFICANT IMPROVEMENT (ENGEL II, 16.7%), AND 2 PATIENTS SHOWED WORTHWHILE IMPROVEMENT (ENGEL III, 16.7%). ONE PATIENT DEVELOPED A LEFT SUPERIOR QUADRANTANOPSIA POSTOPERATIVELY. MEAN FOLLOW-UP DURATION WAS 10 MONTHS. CONCLUSION: THIS STUDY CONTRIBUTES TO THE SPARSE LITERATURE IN THIS FIELD BY DEMONSTRATING THE HIGH EFFICACY AND LOW MORBIDITY OF MRGLITT AS A MINIMALLY INVASIVE METHOD OF ABLATION OF EPILEPTIC FOCI IN THE PEDIATRIC POPULATION OF MEDICALLY REFRACTORY LESIONAL EPILEPSY. REPORTED EVENTS: ONE (B)(6) MALE WITH MESIAL TEMPORAL SCLEROSIS DEVELOPED A LEFT SUPERIOR QUADRANTANOPSIA POSTOPERATIVELY. THERE WAS NO UNEXPECTED TECHNICAL ISSUE WITH THIS PATIENT DURING THE PROCEDURE. THE KNOWN RISK OF DEVELOPING A VISUAL FIELD DEFECT WAS DISCUSSED WITH THE PATIENT/FAMILY PREOPERATIVELY. FORTUNATELY, THE LIMITED DEGREE OF THE QUADRANTANOPSIA HAD NOT HAD A SIGNIFICANT IMPACT ON THE PATIENT¿S QUALITY OF LIFE, INCLUDING HIS ABILITY TO OBTAIN A DRIVER¿S LICENSE IN HIS STATE OF RESIDENCE. THIS COMPLICATION HAD NOT RESOLVED IN THIS PATIENT, AND IT WAS SUSPECTED THAT IT WOULD BE A PERMANENT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388521 VISUALASE LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC 9735542

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Disability