BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 12384693 · Received August 30, 2021

    Report

    Report Number
    1723170-2021-02155
    Event Type
    Injury
    Date Received
    August 30, 2021
    Date of Event
    June 1, 2021
    Report Date
    August 30, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ARTICLE. DATE OF EVENT) PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED AS THE EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. ARTICLE CITATION IS INCLUDED. SYSTEM PRODUCT NUMBER AND SERIAL NUMBER NOT PROVIDED IN JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO EVALUATION WAS PERFORMED AS THIS EVENT WAS REPORTED IN LITERATURE. 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: KATHERINE C. PEHLIVAN, PARITOSH C. KHANNA, JENNIFER D. ELSTER, MEGAN ROSE PAUL, MICHAEL L. LEVY, JOHN R. CRAWFORD, DAVID D. GONDA. CLINICAL AND NEUROIMAGING FEATURES OF MAGNETIC RESONANCE GUIDED STEREOTACTIC LASER ABLATION FOR NEWLY DIAGNOSED AND RECURRENT PEDIATRIC BRAIN TUMORS: A SINGLE INSTITUTIONAL SERIES. WORLD NEUROSURG. (2021) 150:E378-E387. HTTPS://DOI.ORG/10.1016/J.WNEU.2021.03.027. SUMMARY: OBJECTIVE: WE DESCRIBE OUR SINGLE-INSTITUTIONAL EXPERIENCE WITH MAGNETIC RESONANCE-GUIDED STEREOTACTIC LASER ABLATION (SLA) FOR THE TREATMENT OF NEWLY DIAGNOSED AND RECURRENT PEDIATRIC BRAIN TUMORS. METHODS: EIGHTEEN CONSECUTIVE ABLATION PROCEDURES WERE PERFORMED IN 17 PATIENTS FROM MARCH 2016-APRIL 2020. PATIENT DEMOGRAPHICS, INDICATIONS, PROCEDURES, NEUROIMAGING FEATURES, AND OUTCOMES WERE REVIEWED RETROSPECTIVELY. RESULTS: SEVENTEEN PATIENTS (MEAN AGE OF 11.4 YEARS, 11 BOYS, 6 GIRLS) UNDERWENT SLA WITH A MEAN FOLLOW-UP OF 24 MONTHS (RANGE: 3-45 MONTHS). TUMOR HISTOLOGIES INCLUDED PILOCYTIC ASTROCYTOMA (N=5), GANGLIOGLIOMA (N=3), LOW GRADE GLIOMA NOT OTHERWISE SPECIFIED (N=4), GLIOBLASTOMA (N=2), MENINGIOMA (N=1), MEDULLOBLASTOMA (N=1), AND METASTATIC MALIGNANT PERIPHERAL NERVE SHEATH TUMOR (N=1). SLA WAS FIRST-LINE THERAPY IN 10 PATIENTS. MEAN PROCEDURE DURATION INCLUDING ANESTHESIA TIME WAS 328 MINUTES (RANGE: 244-529 MINUTES), AND MEAN POSTOPERATIVE LENGTH OF STAY WAS 1.5 DAYS (RANGE 1-5 DAYS). THE COMPLICATION RATE WAS 29%, WHICH INCLUDED 3 PATIENTS WHO EXPERIENCED POSTOPERATIVE MOTOR CHANGES, WHICH RESOLVED WITHIN SEVERAL WEEKS OF SURGERY, 1 PATIENT WITH SELF-LIMITED INTRAOPERATIVE BRADYCARDIA AND HYPOTENSION, AND 1 PATIENT WHO DIED POSTOPERATIVELY DUE TO INTRACRANIAL HEMORRHAGE FROM A DISTANT LESION. TWELVE OF 17 PATIENTS HAD A NEUROIMAGING RESPONSE AFTER SLA (4 COMPLETE RESPONSES, 8 PARTIAL RESPONSES, 1 STABLE DISEASE). PERCENTAGE OF TUMOR SHRINKAGE FROM BASELINE RANGED FROM 33%-100% (MEAN 75%). PATIENTS WITH LOW-GRADE GLIOMA EXHIBITED THE BEST RESPONSES TO SLA (RANGE 3%-100% DECREASE; MEAN 90%; 36% COMPLETE RESPONSE RATE). CONCLUSIONS: SLA IS A MINIMALLY INVASIVE MODALITY FOR THE TREATMENT OF NEWLY DIAGNOSED AND RECURRENT LOW-GRADE PEDIATRIC BRAIN TUMORS. LOW-GRADE GLIOMAEXHIBITED THE BEST RESPONSES. IDENTIFICATION OF IDEAL CANDIDATES FOR SLA, MITIGATION OF PERIOPERATIVE COMPLICATIONS, AND DEMONSTRATION OF LONG-TERM OUTCOMES NEED TO BE BETTER DEFINED IN A CLINICAL TRIAL SETTING. REPORTED EVENT: ONE TWELVE-YEAR-OLD FEMALE PATIENT DIAGNOSED WITH NEUROFIBROMATOSIS TYPE 1 (NF1) GANGLIOGLIOMA EXPERIENCED TRANSIENT LEFT-SIDED WEAKNESS. IT WAS REPORTED THAT THE PATIENT HAD A LARGE OPTIC PATHWAY GLIOMA WITH THALAMIC INVOLVEMENT WHICH HAD PROGRESS DESPITE NUMEROUS CHEMOTHERAPY REGIMENS CAUSING INCREASING WEAKNESS EVEN BEFORE INTERVENTION AND UNDERWENT SEQUENTIAL ABLATION. THE PATIENT EXPERIENCED LEFT-SIDED WEAKNESS IMMEDIATELY AFTER THE FIRST ABLATION WHICH IMPROVE TO BASELINE 4-6 WEEKS LATER. DUE TO THE SUCCESS OF THE ABLATION, THE PATIENT UNDERWENT A SECOND PROCEDURE AND EXPERIENCED WORSENING LEFT-SIDED WEAKNESS WHICH IMPROVED AGAIN WITH PHYSICAL AND OCCUPATIONAL THERAPY. SEE ATTACHED ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284686 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention