BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 13238435 · Received January 12, 2022

    Report

    Report Number
    1723170-2022-00051
    Event Type
    Injury
    Date Received
    January 12, 2022
    Date of Event
    June 17, 2021
    Report Date
    January 12, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENTS IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ACCEPTED 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

    MILLESI, M., PICHLER, L., DENK, C., LUKAS, J., MATULA, C., WADIURA, L. CLINICAL OUTCOME AND TECHNICAL NUANCES AFTER RESECTION OF ORBITAL CAVERNOUS VENOUS MALFORMATIONS¿A SINGLE-CENTER EXPERIENCE. WORLD NEUROSURGERY 153: E244-E249 HTTPS://DOI.ORG/10.1016/J.WNEU.2021.06.0 BACKGROUND: CAVERNOUS VENOUS MALFORMATIONS (CVMS) REPRESENT THE MOST COMMON BENIGN INTRAORBITAL LESIONS. ENLARGING OR SYMPTOMATIC CVMS (PROGRESSIVE PROPTOSIS OR VISUAL DISTURBANCES) ARE TREATED BY SURGICAL RESECTION. FOR THIS, A VARIETY OF DIFFERENT SURGICAL APPROACHES HAVE BEEN DESCRIBED. THE AIM OF THIS STUDY WAS TO PRESENT A CONTEMPORARY SERIES OF ORBITAL CVMS TREATED VIA OPEN MICROSURGICAL APPROACHES. METHODS: IN THIS STUDY, PATIENTS WHO UNDERWENT RESECTION OF ORBITAL CVMS BETWEEN 2002 AND 2019 WERE INCLUDED. PRESENTING SYMPTOMS WERE NOTED AND NEUROOPHTHALMOLOGIC EXAMINATIONS PERFORMED PRE- AND POSTOPERATIVELY. FOR SURGICAL RESECTION, THE LOCATION OF THE ORBITAL CVM AND ITS RELATION TO THE ORBITAL ANATOMY LED TO DECISION-MAKING FOR APPROPRIATE APPROACHES. A COMPARISON BETWEEN ANATOMICAL LOCATION AND SURGICAL OUTCOME WAS PERFORMED. RESULTS: OVERALL, 35 PATIENTS WITH ORBITAL CVMS WERE INCLUDED. MOST COMMON PRESENTING SYMPTOMS WERE PROGRESSIVE PROPTOSIS (43%) AND VISUAL DISTURBANCES (34%). MOST COMMON LOCATION WAS THE LATERAL QUADRANT (37%) FOLLOWED BY THE SUPERIOR QUADRANT (20%). A SUBFRONTAL CRANIOTOMY WAS PERFORMED IN 40% OF CASES FOLLOWED BY A SUPRAORBITAL CRANIOTOMY INCLUDING THE ORBITAL RIM IN 34% OF CASES. FOR SURGICAL EXCISION, A CRYO-PROBE WAS USED IN 30 PATIENTS, AND COMPLETE RESECTION WAS FEASIBLE IN ALL CASES. LOCATION OF A CVM WITHIN THE SUPERIOR QUADRANT WAS ASSOCIATED WITH IMPROVED POSTOPERATIVE RECOVERY OF VISUAL ACUITY. NO DIFFERENCES FOR CLINICAL OUTCOMES WERE OBSERVED DEPENDING ON THE SURGICAL APPROACH. CONCLUSIONS: RESECTION OF ORBITAL CVMS IS INDICATED IN PATIENTS WITH VISUAL DISTURBANCES OR PROGRESSIVE PROPTOSIS. IN THESE, MICROSURGICAL APPROACHES CAN BE USED WITH MINIMAL MORBIDITY FOR COMPLETE REMOVAL OF THESE WELL CIRCUMSCRIBED LESIONS. REPORTABLE EVENTS 2 PATIENTS DEVELOPED A HYPOSPHAGMA THAT ALSO RESOLVED SPONTANEOUSLY. 1 PATIENT DEVELOPED A NEW OCULOMOTOR PALSY AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732249 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other