BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 14206421 · Received April 26, 2022

    Report

    Report Number
    1723170-2022-00618
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    February 24, 2022
    Report Date
    April 26, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURE DATE IS DEPENDENT ON THE DEVICE LOT/SERIAL NUMBER, THEREFORE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CITATION: ONORINI N, SPENNATO P, ORLANDO V, SAVOIA F, CALÌ C, RUSSO C, DE MARTINO L, DE SANTI MS, MIRONE G, RUGGIERO C, QUAGLIETTA L AND CINALLI G (2022) THE CLINICAL AND PROGNOSTIC IMPACT OF THE CHOICE OF SURGICAL APPROACH TO FOURTH VENTRICULAR TUMORS IN A SINGLE-CENTER, SINGLE-SURGEON COHORT OF 92 CONSECUTIVE PEDIATRIC PATIENTS. FRONT. ONCOL. 12:821738. DOI: 10.3389/FONC.2022.821738. ABSTRACT: OBJECTIVE: A SINGLE-INSTITUTION COHORT OF 92 CONSECUTIVE PEDIATRIC PATIENTS HARBORING TUMORS INVOLVING THE FOURTH VENTRICLE, SURGICALLY TREATED VIA THE TELOVELAR OR TRANSVERMIAN APPROACH, WAS RETROSPECTIVELY REVIEWED IN ORDER TO ANALYZE THE IMPACT OF SURGICAL ROUTE ON SURGERY-RELATED OUTCOMES AND CUMULATIVE SURVIVAL. METHODS: CLINICAL, RADIOLOGICAL, SURGICAL, AND PATHOLOGY DETAILS WERE RETROSPECTIVELY ANALYZED. WE SELECTED N = 6 SURGERY-RELATED CLINICAL AND RADIOLOGICAL OUTCOMES: TRANSIENT AND PERMANENT NEUROLOGICAL DEFICITS, DURATION OF ASSISTED VENTILATION, POSTOPERATIVE NEW ONSET MEDICAL EVENTS, POSTOPERATIVE CEREBELLAR MUTISM, AND EXTENT OF RESECTION. WE BUILT UNIVARIATE AND MULTIVARIATE LOGISTIC MODELS TO ANALYZE THE SIGNIFICANCE OF RELATIONSHIPS BETWEEN THE SURGICAL ROUTES AND THE OUTCOMES. CUMULATIVE SURVIVAL (CS) WAS ESTIMATED BY THE COHORT APPROACH. RESULTS: THERE WERE 53 GIRLS AND 39 BOYS (MEAN AGE, 83 MONTHS). TELOVELAR APPROACH WAS PERFORMED IN 51 CASES AND TRANSVERMIAN APPROACH IN 41 CASES. EARLY POSTOPERATIVE MRI STUDIES SHOWED COMPLETE REMOVAL IN 57 CASES (62%) AND MEASURABLE RESIDUAL TUMOR IN 35 CASES (38%). THE AVERAGE TUMOR RESIDUAL VOLUME WAS 1,316 CM3 (RANGE, 0.016¿ 4.231 CM3; MEDIAN VALUE, 0.9875 CM3). RESIDUAL DISEASE WAS MORE OFTEN DETECTED ON IMMEDIATE POSTOP MRI AFTER TELOVELAR APPROACH, BUT THE DIFFERENCE WAS NOT SIGNIFICANT. CEREBELLAR MUTISM WAS OBSERVED IN 10 CASES (11%). NO SIGNIFICANT DIFFERENCE IN THE ONSET OF CEREBELLAR MUTISM WAS DETECTED BETWEEN TELOVELAR AND TRANSVERMIAN APPROACH. THE CHOICE OF SURGICAL APPROACH DID NOT SIGNIFICANTLY MODIFY ANY OTHER POSTOPERATIVE OUTCOME AND 1-/3-YEAR CS OF HIGH-GRADE SURGICALLY TREATED TUMORS. CONCLUSIONS: WITH THE LIMITATION OF A SINGLE-CENTER, SINGLE-SURGEON RETROSPECTIVE SERIES, OUR FINDINGS OFFER SIGNIFICANT DATA TO RECONSIDER THE REAL IMPACT OF THE CHOICE OF THE SURGICAL ROUTE TO THE FOURTH VENTRICLE ON THE INCIDENCE OF CEREBELLAR MUTISM AND SURGERY-RELATED MORBIDITY. THIS SEEMS TO BE IN LINE WITH SOME RECENT REPORTS IN THE LITERATURE. SURGICAL APPROACH TO THE FOURTH VENTRICLE SHOULD BE INDIVIDUALIZED ACCORDING TO THE LOCATION OF THE TUMOR, DEGREE OF VERMIAN INFILTRATION, AND LATERAL AND UPWARD EXTENSION. TELOVELAR AND TRANSVERMIAN APPROACHES SHOULD NOT BE CONSIDERED ALTERNATIVE BUT COMPLEMENTARY. PEDIATRIC NEUROSURGEONS SHOULD FULLY MASTER BOTH APPROACHES AND CHOOSE THE ONE THAT THEY CONSIDER THE BEST FOR THE PATIENT BASED ON A THOROUGH AND CAREFUL EVALUATION OF PREOPERATIVE IMAGING. REPORTED EVENTS: 18 POST-OPERATIVE RADIOLOGICAL ADVERSE EVENTS WERE IDENTIFIED VIA MAGNETIC RESONANCE IMAGING (MRI). 2 OF THE EVENTS WERE NOTED TO REQUIRE SURGICAL INTERVENTION 2 PATIENTS REQUIRED LUMBAR SPINAL DRAINAGE DUE TO PSEUDOMENINGOCELE, CEREBROSPINAL FLUID (CSF) RELATED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621285 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention