BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 20333374 · Received September 30, 2024

    Report

    Report Number
    1723170-2024-02881
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    July 27, 2024
    Report Date
    September 30, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A1, A3-A5) PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    POLICICCHIO, D., BOCCALETTI, R., DIPELLEGRINI, G. CTA-BASED 3D VIRTUAL MODEL FOR PREOPERATIVE SIMULATION AND INTRAOPERATIVE NEURONAVIGATION IN THE SURGICAL TREATMENT OF DISTAL ANTERIOR CEREBRAL ARTERY ANEURYSMS. JOURNAL OF CLINICAL NEUROSCIENCE 127 (2024) 110756. HTTPS://DOI.ORG/10.1016/J.JOCN.2024.110756. OBJECTIVE: THIS STUDY AIMS TO ASSESS THE EFFICACY AND LIMITATIONS OF COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA)- BASED 3D VIRTUAL MODELS FOR PREOPERATIVE SIMULATION AND INTRAOPERATIVE NEURONAVIGATION IN THE SURGICAL TREATMENT OF DISTAL ANTERIOR CEREBRAL ARTERY (DACA) ANEURYSMS. METHODS: A RETROSPECTIVE OBSERVATIONAL STUDY WAS CONDUCTED, ANALYZING PATIENTS WHO UNDERWENT SURGICAL CLIPPING OF DACA ANEURYSMS VIA AN INTERHEMISPHERIC APPROACH FROM 2016 TO 2022. OUTCOMES MEASURED INCLUDED QUALITATIVE ANALYSES OF 3D RECONSTRUCTIONS AGAINST ACTUAL INTRAOPERATIVE ANATOMY, NEURONAVIGATOR ACCURACY, 6-MONTH MODIFIED RANKIN SCALE (MRS), COMPLETE EXCLUSION RATES, AND SURGICAL COMPLICATIONS. PATIENT DEMOGRAPHICS, CLINICAL CHARACTERISTICS, SURGICAL TIMING, AND INTRAOPERATIVE DATA WERE METICULOUSLY DOCUMENTED FOR ANALYSIS. RESULTS: FIFTEEN PATIENTS WERE INCLUDED IN THE STUDY, WITH A MEAN AGE OF 52 YEARS. THE MEAN HUNT-HESS SCORE AT ADMISSION WAS 2.2, ENCOMPASSING 2 UNRUPTURED AND 13 RUPTURED ANEURYSMS. INTRAOPERATIVE ANATOMICAL VISUALIZATION PERFECTLY MATCHED THE PREOPERATIVE 3D MODEL IN 13 CASES, WITH DISCREPANCIES IN TWO. NEURONAVIGATION DEMONSTRATED A MEAN ACCURACY OF 1.76 MM, REMAINING CONSISTENT IN 14 PATIENTS, AND ACCURATELY TRACKING THE PLANNED TRAJECTORY. POSTOPERATIVE COMPLICATIONS OCCURRED IN 26.5 % OF PATIENTS, INCLUDING TWO FATALITIES, WITH NO NAVIGATION-RELATED COMPLICATIONS. INCOMPLETE ANEURYSM OCCLUSION WAS OBSERVED IN ONE CASE. THE MEAN MRS SCORE AT 6 MONTHS WAS 2.46. CONCLUSIONS: THE EMPLOYMENT OF 3D CTA FOR PREOPERATIVE SIMULATION AND INTRAOPERATIVE NEURONAVIGATION HOLDS SIGNIFICANT POTENTIAL IN ENHANCING THE SURGICAL MANAGEMENT OF DACA ANEURYSMS. DESPITE SOME DISCREPANCIES AND TECHNICAL LIMITATIONS, THE OVERALL PRECISION OF PREOPERATIVE SIMULATIONS AND THE STRATEGIC VALUE OF INTRAOPERATIVE NEURONAVIGATION HIGHLIGHT THEIR UTILITY IN IMPROVING SURGICAL OUTCOMES. REPORTED EVENTS: THE NEURONAVIGATION¿S AVERAGE ACCURACY AT THE PROCEDURE¿S START WAS 1.76 ± 0.92 MM (RANGE 0.5¿3 MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602685 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown