BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 12642065 · Received October 15, 2021

    Report

    Report Number
    1723170-2021-02517
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    July 29, 2019
    Report Date
    October 15, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. EVENT DATE IS THE ACCEPTED DATE OF THE PUBLICATION. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT UPON THE DEVICE MODEL/PART NUMBER, 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 · 1

    CITATION: FEDERICO FRIO, DOMENICO SOLARI, LUIGI MARIA CAVALLO, PAOLO CAPPABIANCA, GÉRALD RAVEROT, EMMALUEL JOUANNEAU. OMMAYA RESEVOIR SYSTEM FOR THE TREATMENT OF CYSTIC CRANIOPHARYNGIOMAS: SURGICAL RESULTS IN A SERIES OF 11 ADULT PATIENTS AND REVIEW OF THE LITERATURE. WORLD NEUROSURGERY. HTTPS://DOI.ORG/10.1016/J.WNEU.2019.07.217 ABSTRACT: OBJECTIVES: TREATMENT OF CYSTIC CRANIOPHARYNGIOMAS CAN BE CHALLENGING AND RECURRENCES ARE FREQUENT, EVEN AFTER TOTAL RESECTION. IN SELECTED CASES, LESS AGGRESSIVE SURGERY WITH THE SOLE DRAINAGE OF THE CYST RELIEFS SYMPTOMS CAUSED BY MASS EFFECT AND REPRESENTS A VALID ALTERNATIVE OPTION, NOTABLY IN PEDIATRIC POPULATION. WE HEREIN ANALYZE A SERIES OF ADULT CYSTIC CRANIOPHARYNGIOMAS, MANAGED WITH OMMAYA RESERVOIR IMPLANT, FOCUSING ON LOCAL TUMOR CONTROL AND EVENTUAL COMPLICATIONS. METHODS: 11 NON-CONSECUTIVE ADULT CYSTIC CRANIOPHARYNGIOMAS (7 RECURRENT LESIONS) HAVE BEEN TREATED WITH OMMAYA RESERVOIR SYSTEM (ORS), IN TWO NEUROSURGICAL CENTERS. ORS WAS PLACED IN NINE CASES USING MINIMALLY INVASIVE PROCEDURES: SIX BURR HOLE ENDOSCOPIC INSERTION AND THREE NAVIGATED ELECTROMAGNETIC PLACEMENT; IN THE REMAINING TWO PATIENTS, THE OMMAYA RESERVOIR WAS USED AS A SHUNT TO PREVENT CYST RECOLLECTION DURING A TRANSCRANIAL APPROACH. RESULTS: THE MAIN PRESENTING SYMPTOMS WERE VISUAL IMPAIRMENT (75%), COGNITIVE AND BEHAVIORAL DISORDERS (66.7%), HYPOPITUITARISM (38%), HEADACHE (30.8%) AND HYPOTHALAMIC OBESITY (8%). THE MEDIAN FOLLOW-UP PERIOD WAS 41.4 MONTHS. IN ALL PATIENTS THE VISUAL FUNCTION AND INTRACRANIAL HYPERTENSION IMPROVED AFTER DECOMPRESSION. LOCAL TUMOR CONTROL WAS ACCOMPLISHED IN EIGHT PATIENTS (72.7%), WITHOUT THE NEED OF ADJUVANT TREATMENTS. THE ENDOSCOPIC VISION CARRIED SIMILAR RATES OF TUMOR CONTROL THAN STEREOTAXY (75% VS 66.7%). CONCLUSIONS: IN SELECTED PATIENTS, TAILORED PROCEDURES ARE REQUIRED TO ACHIEVE LONG-TERM TUMOR CONTROL AND AS WELL LIMIT SURGERY-RELATED MORBIDITY. ORS COULD REPRESENT A SAFE AND EFFECTIVE TREATMENT OPTION FOR CYSTIC CRANIOPHARYNGIOMAS, PROVIDING ALSO REDUCED SURGICAL RELATED MORBIDITY ESPECIALLY IN RECURRENT LESIONS AND IN PATIENTS NON SUITABLE FOR RADICAL SURGERY. REPORTED EVENTS: ONE PATIENT EXPERIENCED AN OMMAYA INFECTION TWO WEEKS AFTER THE NEUROENDOSCOPIC PLACEMENT WHICH REQUIRED SYSTEM REMOVAL. ONE INSTANCE OF STEREOTACTIC CATHETER MALPOSITIONING, WHICH REQUIRED A STEREOTACTIC REPLACEMENT. ONE PATIENT EXPERIENCED A CEREBROSPINAL FLUID (CSF) LEAKAGE AROUND THE SUBCUTANEOUS RESERVOIR THAT WAS DERIVED WITH A MENINGO-PERITONEAL SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535590 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention