BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 12855901 · Received November 22, 2021

    Report

    Report Number
    1723170-2021-02736
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    August 20, 2021
    Report Date
    November 22, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE FOR SECTION FOREIGN, LITERATURE, HEALTH PROFESSIONAL. 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.

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS UNAVAILABLE 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

    ZHANG, Y., TU, S., DUAN, L., FU, W., WANG, J., GENG, S., CLASSIFICATION OF PITUITARY ADENOMAS INVADING THE CAVERNOUS SINUS ASSISTED BY THREE-DIMENSIONAL MULTIMODAL IMAGING AND ITS CLINICAL APPLICATION. JOURNAL OF NEUROLOGICAL SURGERY. 2021; 82:567¿575. DOI HTTPS://DOI.ORG/ 10.1055/S-0040-1715597. INTRODUCTION TO HELP DIAGNOSE AND EVALUATE THE PROGNOSIS OF PITUITARY ADENOMA WITH CAVERNOUS SINUS (CS) INVASION AND GUIDE ENDONASAL ENDOSCOPIC SURGERY (EES) ASSISTED BY INTRAOPERATIVE NAVIGATION (ION) WITH THREE-DIMENSIONAL MULTIMODAL IMAGING (3DMMI). WE PROPOSE A CLASSIFICATION OF CS INVASION BASED ON 3D-MMI. METHODS WE PICKED SOME APPROPRIATE CASES AND RECONSTRUCTED THE 3D-MMI AND THEN CLASSIFIED THEM INTO 3 GRADES ACCORDING TO THE STEREO RELATIONSHIP AMONG ICA, TUMOR AND CS IN 3D-MMI. THEN, WE APPLIED DIFFERENT STRATEGIES ACCORDING TO THEIR GRADE TO REMOVE PITUITARY ADENOMAS THAT INVADED THE CS. RESULTS ALL 38 PATIENTS WERE DIVIDED INTO 3 GRADES. TUMORS COMPRESSING THE ICA AND CS WITHOUT CS INVASION WERE DIVIDED INTO GRADE 1. TUMORS ENCASING THE ICA AND INVADING THE SUPERIOR-POSTERIOR COMPARTMENT AND/OR ANTERIOR-INFERIOR COMPARTMENT BUT WITHOUT DISTINCT SEPARATION OF THE ICA AND CS LATERAL WALL WERE DEEMED AS GRADE 2. TUMORS ENCASING THE ICA AND FILLING THE LATERAL COMPARTMENT OF THE CS THAT DISSOCIATED THE LATERAL WALL FROM THE ICA WERE DEEMED AS GRADE 3. THE 3D-MMI ENABLED ADEQUATE SPATIAL VISUALIZATION OF THE ICA, CS AND TUMORS. ALL PATIENTS WERE OPERATED ON UNDER THE GUIDANCE OF ION WITH 3D-MMI. CONCLUSION CLASSIFICATION BASED ON 3D-MMI CAN BETTER DEMONSTRATE THE RELATIONSHIPS AMONG TUMOR, ICA AND CS IN A STEREO AND MULTI-ANGLE VIEW, WHICH WILL HAVE SIGNIFICANCE IN GUIDING THE SURGICAL STRATEGY REPORTABLE EVENTS: THE DEGREE OF BLEEDING WAS RELATIVELY HIGHER THAN GRADE 1. THE INFERIOR CAVERNOUS SINUS ARTERY AND/OR BRANCHES OF THE MENINGOHYPOPHYSEAL TRUNK NEEDED TO BE COAGULATED. THERE MAY HAVE BEEN MORE BLEEDING THAN GRADE 2, BUT WHEN THE TUMOR WAS REMOVED, BLEEDING COULD BE STOPPED EASILY WITH A GELATIN SPONGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748574 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other