BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 14521663 · Received May 27, 2022

    Report

    Report Number
    1723170-2022-00820
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    December 3, 2021
    Report Date
    May 27, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 ONLINE PUBLISHING DATE OF THE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, 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

    CITATION: CHIMAN JEON, MD, JUNG WON CHOI, MD, PHD, DOO-SIK KONG, MD, PHD, AND HYUNG JIN SHIN, MD, PHD. OUTCOME OF ENDOSCOPIC TRANSCORTICAL INT RAVENTRICULAR BIOPSY OF ISOLATED THICKENED PITUITARY STALK LESIONS IN CHILDREN. J NEUROSURGERY PEDIATRICS (22) 2022. DOI: 10.3171/2021.9.PEDS21254. ABSTRACT: OBJECTIVE THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE EFFICACY AND SAFETY OF ENDOSCOPIC TRANSCORTICAL INTRAVENTRICULAR BIOPSY IN PEDIATRIC PATIENTS WITH ISOLATED THICKENED PITUITARY STALK LESIONS. METHODS FROM 1994 TO 2018, 16 PEDIATRIC PATIENTS (8 MALES AND 8 FEMALES) UNDERWENT ENDOSCOPIC TRANSCORTICAL INTRAVENTRICULAR BIOPSY AT A SINGLE INSTITUTION TO ESTABLISH AN ACCURATE PATHOLOGICAL DIAGNOSIS FOR APPROPRIATE TREATMENT STRATEGIES. RESULTS PREOPERATIVELY, THE MEDIAN DIAMETER OF THE PITUITARY STALKS WAS 5.31 ± 1.67 MM (RANGE 3.86¿9.17 MM). OVERALL, THE DIAGNOSTIC YIELD AT ENDOSCOPIC INTRAVENTRICULAR BIOPSY WAS 93.8%. HISTOPATHOLOGICAL DIAGNOSIS INCLUDED GERMINOMA (N = 10, 62.5%), LANGERHANS CELL HISTIOCYTOSIS (N = 4, 25%), PILOCYTIC ASTROCYTOMA (N = 1, 6.3%), AND PITUICYTOMA (N = 1, 6.3%). TWO PATIENTS DEVELOPED NEW DIABETES INSIPIDUS AFTER THE PROCEDURE, AND 3 PATIENTS HAD NEW POSTOPERATIVE HYPOTHYROIDISM. THERE WERE NO POSTOPERATIVE NEUROLOGICAL DEFICITS IN THIS SERIES. CONCLUSIONS NEUROENDOSCOPIC BIOPSY VIA THE TRANSCORTICAL INTRAVENTRICULAR CORRIDOR WAS SHOWN TO BE SAFE AND TO AID IN A RELIABLE HISTOPATHOLOGICAL DIAGNOSIS IN THE MANAGEMENT OF ISOLATED PITUITARY STALK LESIONS IN PEDIATRIC PATIENTS. IT CAN BE CONSIDERED A MINIMALLY INVASIVE ALTERNATIVE TO OPEN BIOPSY VIA TRANSCRANIAL OR ENDONASAL CORRIDORS. COMPLICATIONS: TWO PATIENTS DEVELOPED A NEW DI AFTER THE PROCEDURE. THREE PATIENTS EXPERIENCED NEW POST-OPERATIVE HYPOTHYROIDISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2763067 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male Required Intervention