BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 18312480 · Received December 12, 2023

    Report

    Report Number
    1723170-2023-02730
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    August 18, 2021
    Report Date
    December 12, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE 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 IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    WAKABAYASHI, T., HIROSE, Y., MIYAKE, K., ARAKAWA, Y., KAGAWA, N., NARIAI, T., NARITA, Y., NISHIKAWA, R., TSUYUGUCHI, N., FUKAMI, T., SASAKI, H., SASAYAMA, T., KONDO, A., IUCHI, T., MATSUDA, H., KUBOTA, K., MINAMIMOTO, R., TERAUCHI, T., NAKAZATO, Y., KUBOMURA, K., WADA, M. DETERMINING THE EXTENT OF TUMOR RESECTION AT SURGICAL PLANNING WITH 18F-FLUCICLOVINE PET/CT IN PATIENTS WITH SUSPECTED GLIOMA: MULTICENTER PHASE III TRIALS. ANNALS OF NUCLEAR MEDICINE (2021) 35:1279-1292 HTTPS://DOI.ORG/10.1007/S12149-021-01670-Z OBJECTIVE: GLIOMA IS THE MOST COMMON TYPE OF CENTRAL NERVOUS SYSTEM TUMOR REPORTED WORLDWIDE. CURRENT IMAGING TECHNOLO-GIES HAVE LIMITATIONS IN THE DIAGNOSIS AND ASSESSMENT OF GLIOMA. THE PRESENT STUDY AIMED TO CONFIRM THE DIAGNOSTIC EFFICACY AND SAFETY OF ANTI-1- AMINO-3-[18F]FLUOROCYCLOBUTANE CARBOXYLIC ACID (18F-FLUCICLOVINE; ANTI-[18F]FACBC) AS A RADIOTRACER FOR PATIENTS UNDERGOING COMBINED POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET/CT) FOR SUSPECTED GLIOMA. METHODS: COMBINED DATA FROM TWO MULTICENTER, OPEN-LABEL PHASE III CLINICAL TRIALS WERE EVALUATED FOR THIS STUDY. THE TWO TRIALS ENROLLED PATIENTS WITH SUSPECTED HIGH- OR LOW-GRADE GLIOMA ON THE BASIS OF CLINICAL SYMPTOMS, CLINICAL COURSE, AND MAGNETIC RESONANCE IMAGING FINDINGS, AND WHO WERE SCHEDULED FOR TUMOR RESECTION SURGERY. PATIENTS FASTED FOR = 4 H AND RECEIVED 2 ML OF 18F-FLUCICLOVINE (RADIOACTIVITY DOSE 78.3¿297.0 MBQ), FOLLOWED BY A 10-MIN PET SCAN 10¿50 MIN AFTER INJECTION. THE PRIMARY EFFICACY ENDPOINT WAS THE POSITIVE PREDICTIVE VALUE (PPV) OF THE GADOLINIUM CONTRAST-ENHANCED T1-WEIGHTED IMAGE NEGATIVE [GD (¿)] AND 18F-FLUCICLOVINE PET-POSITIVE [PET ( +)] AREA OF THE SCANS, USING THE HISTOPATHOLOGICAL DIAGNOSIS OF THE TISSUE SAMPLED FROM THAT AREA AS THE STANDARD OF TRUTH. ALL ADVERSE EVENTS REPORTED DURING THE STUDY WERE RECORDED FOR SAFETY ANALYSIS. RESULTS: A TOTAL OF 45 PATIENTS AGED 23¿89 YEARS UNDERWENT 18F-FLUCICLOVINE PET; 31/45 PATIENTS (68.9%) WERE MALE, AND 30/45 PATIENTS (66.7%) WERE SUSPECTED TO HAVE HIGH-GRADE GLIOMA. THE PPV OF 18F-FLUCICLOVINE PET IN THE GD (¿) PET ( +) AREA WAS 88.0% (22/25 AREAS, 95% CONFIDENCE INTERVAL: 70.0¿95.8). THE EXTENT OF PLANNED TUMOR RESECTION WAS MODIFIED IN 47.2% (17/36 CASES) AFTER 18F-FLUCICLOVINE PET SCAN, WITH AN EXTENSION OF AREA IN 30.6% (11/36 CASES) AND REDUCTION IN 16.7% (6/36 CASES). FURTHERMORE, TISSUE SAMPLES COLLECTED FROM PET ( +) AREAS TENDED TO HAVE A HIGHER MALIGNANCY GRADE COMPARED WITH THOSE FROM PET (¿) AREAS. OVERALL, 18F-FLUCICLOVINE WAS WELL TOLERATED. CONCLUSION: 18F-FLUCICLOVINE PET/CT IS USEFUL FOR DETERMINING THE EXTENT OF TUMOR RESECTION AT SURGICAL PLANNING, AND MAY SERVE AS A SAFE AND EFFECTIVE DIAGNOSTIC TOOL FOR PATIENTS WITH SUSPECTED GLIOMA. TRIAL REGISTRATION THESE TRIALS WERE REGISTERED IN THE JAPAN PHARMACEUTICAL INFORMATION CENTER CLINICAL TRIALS INFORMATION (JAPICCTI -152986, JAPICCTI-152985). REPORTED EVENTS: ONE PATIENT WITH THIRST, THIS EVENT WAS JUDGED BY THE INVESTIGATORS AS HAVING A CAUSAL RELATIONSHIP WITH 18F-FLUCICLOVINE. ONE PATIENT WITH SWELLING OF THE PUNCTURED INTRAVENOUS SITE THREE OF THE 25 TISSUE SAMPLES COLLECTED FROM A GD (¿) PET ( +) AREA WERE PATHOLOGICALLY RATED AS TUMOR-FREE IN THE PRESENT STUDY. THE REASON FOR THIS DISCREPANCY SEEMED TO BE A SAMPLING ERROR IN TWO CASES (A DIFFERENCE BETWEEN THE TIS-SUE COLLECTION SITE AND THE NAVIGATION IMAGE, AND TISSUE SHIFT AT THE TIME OF BIOPSY) SEE ATTACHED LITERATURE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303633 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention