BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17912499 · Received October 11, 2023

    Report

    Report Number
    1723170-2023-01925
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    June 25, 2022
    Report Date
    October 11, 2023
    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. 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 ACCEPTED 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

    ZOLI, M., GUARALDI, F., ZENESINI, C., ACCIARRI, N., SOLLINI, G., ASIOLI, S., FAUSTINI-FUSTINI, M., AGATI, R., CIRILLO, L., TONON, C., LODI, R., PASQUINI, E., MAZZATENTA, D. ROLE OF ENDOSCOPIC ENDONASAL APPROACH FOR CRANIOPHARYNGIOMAS EXTENDING INTO THE THIRD VENTRICLE IN ADULTS. BRAIN AND SPINE. 2022. 2 (100910) HTTPS://DOI.ORG/10.1016/J.BAS.2022.100910 SURGERY OF CRANIOPHARYNGIOMAS EXTENDING INTO THE THIRD VENTRICLE (3VCPS) IS CHALLENGING FOR THE RISK OF SEVERE AND PERMANENT CLINICAL SEQUELAE, AND EVEN OF FATAL COMPLICATIONS (AHMED ET AL., 2018; ALMEIDA ET AL., 2020; APUZZO ET AL., 1982, 1991; HARDESTY ET AL., 2018). IN THE LAST YEARS, THE ENDOSCOPIC ENDONASAL APPROACH (EEA) HAS BEEN PROPOSED FOR THE MANAGEMENT OF 3CVPS TO REDUCE PATIENT MORBIDITY AND IMPROVE SURGICAL OUTCOMES (HARDESTY ET AL., 2018; CAGNAZZO ET AL., 2018; CHA-MOUN AND COULDWELL, 2013; COPPENS AND COULDWELL, 2010; FORBES ET AL., 2018; JEAN, 2018; LIU, 2013; SHUKLA, 2015; SILVA ET AL., 2013; ZIELI N SKI ET AL., 2018). EEA WAS INITIALLY INDICATED ONLY FOR THE TREATMENT OF TUMORS WITH NO OR LIMITED SUPRA-DIAPHRAGMATIC EXTENSION. SUBSEQUENT STUDIES HAVE PRO-GRESSIVELY DEMONSTRATED ITS EFFECTIVENESS AND SAFETY EVEN FOR LARGER TU-MORS WITH A SUPRASELLAR EXPANSION (HARDESTY ET AL., 2018; CAVALLO ET AL., 2014; COSSU ET AL., 2020; TODESCHINI ET AL., 2018). INDEED, SYSTEMATIC REVIEWS AND META-ANALYSES HAVE DEMONSTRATED A SIGNIFICANT REDUCTION OF NEUROLOGICAL SEQUELAE (I.E., CRANIAL NERVES PALSIES, POST-OPERATIVE SEI-ZURES, NEUROLOGICAL DEFICITS) TOGETHER WITH THE IMPROVEMENT OF THE VISUAL OUTCOME ASSOCIATED WITH EEA, THANKS TO THE LIMITED BRAIN RETRACTION AND ARTERO-NERVOUS STRUCTURES MANIPULATION (CAVALLO ET AL., 2014; COSSU ET AL., 2020; TODESCHINI ET AL., 2018; ALGATTAS ET AL., 2020). HOWEVER, EEA STILL PRESENTS SOME LIMITATIONS, AS, THE DIFFICULTY IN MANAGING NON-PURELY MIDLINE LESIONS AND TUMORS ENCASING THE MAIN ARTERIES AND IS BURDENED BY A NOT NEGLIGIBLE RATE OF POST-OPERATIVE CSF LEAK, WITH THE CONSEQUENT RISK OF POST-OPERATIVE MENINGITIS (ALMEIDA ET AL., 2020; CAVALLO ET AL., 2014; COSSU ET AL., 2020; TODESCHINI ET AL., 2018; ALGATTAS ET AL., 2020). NOWADAYS, ONLY FEW STUDIES HAVE INVESTIGATED THE OUTCOMES OF EEA FOR 3VCPS, AND DESPITE THEIR ENCOURAGING RESULTS, THE ROLE OF EEA ITS SELECTION FOR 3VCPS AND CRITERIA REMAIN TO BE ASCERTAINED (CAVALLO ET AL., 2014; ALGATTAS ET AL., 2020; KOUTOUROUSIOU ET AL., 2018; LENG ET AL., 2012; FOMICHEV ET AL., 2016). AIMS OF THIS STUDY WERE TO ASSESS THE OUTCOME OF EEA IN A LARGE SERIES OF 3VCPS; DEFINING ITS ADVANTAGES AND LIMITATIONS; AND TO IDENTIFY THE FACTORS FAVORING THE CHOICE OF THIS APPROACH, BASED ON WHICH WE PROPOSED A FLOW-CHART TO GUIDE THE APPROACH SELECTION FOR 3VCPS. REPORTABLE EVENTS: THE MOST FREQUENT COMPLICATION WAS POST-OPERATIVE CSF LEAK, OVERALL OCCURRING IN 5 CASES (13.9%) 3 PATIENTS DEVELOPED MENINGITIS (8.3%) THAT WAS TREATED WITH I.V. ANTIBIOTIC THERAPY, WITH NO NEUROLOGICAL SEQUELAE. ONE PATIENT (2.8%) PRESENTED WITH SUDDEN LOSS OF CONSCIOUSNESS IN THE FIRST DAY AFTER SURGERY, DUE TO A 3RD VENTRICLE HEMATOMA. AN EXTERNAL VENTRICULAR DRAINAGE WAS IMMEDIATELY INSERTED TO TREAT HYDROCEPHALUS, FOLLOWED BY EEA SURGERY TO REMOVE THE CLOTS AND DECOMPRESS THE SURROUNDING NEURAL STRUCTURES. ANOTHER PATIENT DEVELOPED POST-OPERATIVE EPISTAXIS DUE TO THE BLEEDING OF A BRANCH OF THE SPHENO-PALATINE ARTERY, REQUIRING RE-INTERVENTION FOR CAUTERIZATION. ONE PATIENT PRESENTED WITH TRANSITORY PALSY OF THE 3RD CRANIAL NERVE ONE PATIENT HAD TRANSITORY MEMORY DISTURBANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238148 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention