BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 13060978 · Received December 22, 2021

    Report

    Report Number
    1723170-2021-02944
    Event Type
    Death
    Date Received
    December 22, 2021
    Date of Event
    September 12, 2021
    Report Date
    December 22, 2021
    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 IS THE MEAN VALUE OF PATIENTS IN THE STUDY. 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 DEPENDENT UPON THE DEVICE MODEL NUMBER AND IS THEREFORE, 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

    DI BONAVENTURA, R., MONTANO, N., GIORDANO, M., GESSI, M., GAUDINO, S., IZZO, A., MATTOGNO, P.P., STUMPO, V., CACCAVELLA, V.M., GIORDANO, C., LAURETTI, L., COLOSIMO, C., GIORGIO D¿ALESSANDRIS, Q., PALLINI, R., OLIVI, A. REASSESSING THE ROLE OF BRAIN TUMOR BIOPSY IN THE ERA OF ADVANCED SURGICAL, MOLECULAR, AND IMAGING TECHNIQUES¿ A SINGLE-CENTER EXPERIENCE WITH LONG-TERM FOLLOW-UP. JOURNAL OF PERSONALIZED MEDICINE. 2021 (11:9) 1-10. HTTPS://DOI.ORG/10.3390/ JPM11090909. ABSTRACT: BRAIN BIOPSY IS THE GOLD STANDARD IN ORDER TO ESTABLISH THE DIAGNOSIS OF UNRESECTABLE BRAIN TUMORS. FEW STUDIES HAVE INVESTIGATED THE LONG-TERM OUTCOMES OF BIOPSY PATIENTS. THE AIM OF THIS SINGLE-INSTITUTION-BASED STUDY WAS TO ASSESS THE CONCORDANCE BETWEEN RADIOLOGICAL AND HISTOPATHOLOGICAL DIAGNOSES, AND THE LONG-TERM PATIENT OUTCOME. NINETY-THREE PATIENTS WHO UNDERWENT BRAIN BIOPSY IN THE LAST 5 YEARS WERE ANALYZED. WE INCLUDED PATIENTS TREATED WITH STEREOTACTICALLY GUIDED NEEDLE, OPEN, AND NEUROENDOSCOPIC BIOPSIES. MOST PATIENTS (86%) RECEIVED NEEDLE BIOPSY. GLIOMAS AND PRIMARY BRAIN LYMPHOMAS COMPRISED 88.2% OF CASES. THE DIAGNOSTIC YIELD WAS 95.7%. SERIOUS COMPLICATION AND DEATH RATES WERE 3.2% AND 2.1%, RESPECTIVELY. THE CONCORDANCE RATE BETWEEN RADIOLOGICAL AND HISTOLOGICAL DIAGNOSES WAS 93%. NOTABLY, THE POSITIVE PREDICTIVE VALUE OF RADIOLOGICAL DIAGNOSIS OF LYMPHOMA WAS 100%. BIOPSY ALLOWED SPECIFIC TREATMENT IN 72% OF CASES. DISEASE-RELATED NEUROLOGICAL WORSENING WAS THE MAIN REASON THAT PRECLUDED ADJUVANT TREATMENT. ADJUVANT TREATMENT, IN TURN, WAS THE STRONGEST PROGNOSTIC FACTOR, SINCE THE MEDIAN OVERALL SURVIVAL WAS 11 MONTHS WITH VS. 2 MONTHS WITHOUT TREATMENT (P = 0.0002). FINALLY, ADVANCED MOLECULAR EVALUATIONS CAN BE OBTAINED ON GLIOMA BIOPSY SPECIMENS TO PROVIDE INTEGRATED DIAGNOSES AND INDIVIDUALLY TAILORED TREATMENTS. WE CONCLUDE THAT, DESPITE THE HUGE ADVANCES IN IMAGING TECHNIQUES, BIOPSY IS REQUIRED WHEN AN ADJUVANT TREATMENT IS RECOMMENDED, PARTICULARLY IN GLIOMAS. REPORTABLE EVENTS: POST-OPERATIVE BRAIN EDEMA WAS RECORDED IN TWO PATIENTS, RESULTING IN SEVERE NEUROLOGICAL IMPAIRMENT LEADING TO DEATH IN TWO OF THE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965961 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Death