BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUALASE

    MDR report key: 11039819 · Received December 18, 2020

    Report

    Report Number
    1723170-2020-03333
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    February 12, 2013
    Report Date
    December 18, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS THE PUBLICATION DATE OF THE ABSTRACT. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. FACILITY AND ADDRESS NOT POPULATED AS THE FACILITY WAS NOT PROVIDED IN THE ABSTRACT PROVIDED. 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: MINIMALLY INVASIVE STEREOTACTIC LASER ABLATION (SLA) OF HYPOTHALAMIC HAMARTOMAS (HH) CURRY D.; WILFONG A.; CASCINO G.; WORRELL G.; MARSH R.; VISWANATHAN A.; YOSHOR D.; TAKEOKA M.; MADSEN J.; SHETTY A. NEUROLOGY (2013) 80:1 MEETING ABSTRACTS. DATE OF PUBLICATION: 12 FEB 2013 OBJECTIVE: TO STUDY THE FEASIBILITY OF MINIMALLY-INVASIVE STEREOTACTIC LASER ABLATION FOR EPILEPTOGENIC HH. BACKGROUND: SURGICAL INTERVENTION FOR HH HAS BEEN LIMITED DUE TO MODEST OUTCOMES (37- 50% SEIZURE FREEDOM), DIFFICULT LOCATION, AND ASSOCIATED SURGICAL MORBIDITY (7-10% PERMANENT). STEREOTACTIC RADIOSURGERY HAS ALSO DEMONSTRATED MODEST RESULTS. SEIZURES ARE PRIMARILY GELASTIC, MEDICALLY INTRACTABLE AND MAY OCCUR EVERY FEW MINUTES. PATIENTS OFTEN DEVELOP PROGRESSIVE INTELLECTUAL DETERIORATION AND DISORDERED BEHAVIOR. DESIGN/METHODS: PATIENTS (N=13 PED:11 ADULT:2) WITH INTRACTABLE GELASTIC EPILEPSY UNDERWENT STEREOTACTIC FRAME-BASED PLACEMENT OF MR-COMPATIBLE LASER CATHETER (1.6MM DIA) THROUGH A 3.2MM TWIST DRILL HOLE. AN FDA-CLEARED LASER SURGERY SYSTEM (VISUALASE; VISUALASE, INC., HOUSTON, TX) WAS UTILIZED TO MONITOR THE ABLATION OF EPILEPTOGENIC FOCI WITH REAL-TIME MRI THERMOMETRY. AFTER CONFIRMATION TEST AT ~ 3W, HIGHER DOSES OF 6-10 W FOR 50-120 SECONDS WERE USED FOR SLA. TEMPERATURE LIMITS WERE SET TO PROTECT NEARBY STRUCTURES LIKE THE HYPOTHALAMUS, BASILAR ARTERY, FORNICES, OR MAMILLOTHALAMIC TRACTS. RESULTS: THERE WERE NO PERMANENT SURGICAL COMPLICATIONS, NEUROLOGICAL DEFICITS, OR NEUROENDOCRINE DISTURBANCES. ONE PT HAD TRANSIENT DI, ANOTHER WITH PROLONGED HOSPITALIZATION AFTER DILANTIN TOXICITY, AND ANOTHER WITH A MINOR SUBARACHNOID HEMORRHAGE. THE AVERAGE LOS WAS 2 DAYS. SEIZURE FREEDOM WAS OBTAINED IN 8 OF THE 13 CASES (61%), 72% IN THE PEDIATRIC PATIENTS. ENGEL 1 STATUS WAS ACHIEVED IN 2 OF THE 3 CASES. CONCLUSIONS: SLA WAS DEMONSTRATED TO BE A SAFE AND EFFECTIVE MINIMALLY INVASIVE TOOL TO TREAT HH. SEIZURE FREEDOM WAS ACHIEVED WITHOUT SURGICAL COMORBIDITY AND REDUCED LOS. REAL-TIME MRI THERMOMETRY ENABLED PROTECTION OF ADJACENT CRITICAL STRUCTURES. THE BEST RESULTS FROM TREATMENT OF THE HH WILL LIKELY RESULT IF THE TREATMENT OCCURS BEFORE THE EVOLUTION OF THE SEIZURE PATTERN INTO A WIDESPREAD SECONDARY GENERALIZED EPILEPSY. SLA PROVIDES A PRECISE MINIMALLY INVASIVE TOOL IN THE NEUROSURGEON'S ARMAMENTARIUM FOR FIRST-LINE INTERVENTION AND IN CASES WHERE SRS AND SURGERY HAVE FAILED. REPORTED EVENT(S): 1. ONE PATIENT HAD TRANSIENT DI 2. ONE PATIENT EXPERIENCED PROLONGED HOSPITALIZATION AFTER DILANTIN TOXICITY 3. ONE PATIENT EXPERIENCED A MINOR SUBARACHNOID HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507262 VISUALASE LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC 9735542

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R