BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE/SHUNT

    MDR report key: 7015735 · Received November 9, 2017

    Report

    Report Number
    2021898-2017-00569
    Event Type
    Injury
    Date Received
    November 9, 2017
    Report Date
    November 9, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED IS NOTED IN EACH EVENT AS KNOWN. THIS EVENT WAS IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    JEHUDA SOLEMAN, HAGGAI BENVENISTI, SHLOMI CONSTANTINI, JONATHAN ROTH. CONVERSION OF EXTERNAL VENTRICULAR DRAINAGE TO VENTRICULO-PERITONEAL SHUNT: TO CHANGE OR NOT TO CHANGE THE PROXIMAL CATHETER? CHILD'S NERVOUS SYSTEM (2017). DOI 10.1007/S00381-017-3544-5 ABSTRACT PURPOSE IN THIS STUDY, WE INVESTIGATE THE OCCURRENCE RATE OF EARLY SHUNT INFECTION AND MALFUNCTION IN PEDIATRIC PATIENTS AFTER CONVERTING AN EXTERNAL VENTRICULAR DRAINAGE (EVD) TO A VENTRICULO-PERITONEAL SHUNT (VPS) WITHOUT REPLACING THE VENTRICULAR CATHETER. METHODS DATA WAS RETROSPECTIVELY REVIEWED FOR 17 PEDIATRIC PATIENTS (11 MALE (64.7%), MEAN AGE 7.5 YEARS, RANGE 0.25¿15 YEARS) WHO UNDERWENT 18 CONSECUTIVE DIRECT CONVERSIONS OF TUNNELED EVD TO VPS WITHOUT REPLACING THE VENTRICULAR CATHETER BETWEEN 2008 AND 2017. IN EACH CASE, THE EVD WAS INSERTED IN STERILE FASHION WITHIN THE OPERATING ROOM AND TUNNELED SUBCUTANEOUSLY 5¿7 CM AWAY FROM THE INSERTION SITE. PRIMARY OUTCOME MEASURE WAS THE OCCURRENCE OF EARLY (WITHIN 30 DAYS) VPS INFECTION OR MALFUNCTION. THE MEAN FOLLOW-UP TIME WAS 56.8 MONTHS (±35.7 MONTHS). RESULTS THE MEAN PERIOD OF EVD BEFORE VPS PLACEMENT WAS 9.0 DAYS (±3.6 DAYS, RANGE 2¿18 DAYS).FIVE PATIENTS HAD SHUNT INFECTIONS/MALFUNCTIONS. ONE PATIENT (5.6%) HAD AN EARLY SHUNT INFECTION AFTER 30 DAYS. ONE PATIENT HAD A LATE SHUNT INFECTION AFTER 9 MONTHS. ONE PATIENT HAD AN EARLY SHUNT MALFUNCTION AFTER 9 DAYS. TWO PATIENTS (11.1%) HAD LATE SHUNT MALFUNCTIONS AFTER 6.5 MONTHS AND 9 YEARS. THERE WERE NO OTHER INCIDENTS OF SHUNT-RELATED COMPLICATIONS OR SHUNT RELATED MORTALITY. CONCLUSION IN THE PEDIATRIC POPULATION, THE CONVERSION OF A TUNNELED EVD TO A VPS WITHOUT REPLACING THE VENTRICULAR CATHETER CAN BE SAFELY DONE. CRANIAL ENTRY IS SPARED, WHILE THE RATES OF SHUNT INFECTION AND MALFUNCTION DO NOT INCREASE SIGNIFICANTLY. REPORTED EVENTS: A (B)(6) YEAR OLD MALE HAD AN EARLY SHUNT INFECTION OCCUR AFTER 30 DAYS. THIS PATIENT PRESENTED AT AN EARLY AGE WITH AN INFECTED SHUNT (ESCHERICHIA COLI AND CANDIDA) 4 YEARS AFTER SHUNT PLACEMENT (THE SHUNT WAS ORIGINALLY INSERTED DUE TO A TRAPPED 4TH VENTRICLE IN ASSOCIATION WITH A DANDY WALKER MALFORMATION). THE SHUNT WAS EXTERNALIZED, ANTIBIOTIC AND ANTIFUNGAL MEDICATION WAS ADMINISTERED, AND ONCE CULTURES WERE NEGATIVES, IT WAS REPLACED BY A NEW SHUNT SYSTEM. TWO YEARS LATER, THE PATIENT PRESENTED WITH SUSPECTED ABDOMINAL INFECTION. THE SHUNT WAS EXTERNALIZED, AND ONCE PROVEN INFECTED ((B)(6)), THE SHUNT WAS REMOVED AND AN EVD WAS PLACED. AFTER OBTAINING STERILE CSF CULTURES, THE EVD WAS CONVERTED AFTER 8 DAYS TO A VENTRICULO-ARTERIAL SHUNT (VAS). THIRTY DAYS LATER, THE PATIENT PRESENTED WITH FEVER AND NEUROLOGICAL DECLINE CAUSED BY (B)(6) SHUNT INFECTION. THE SHUNT WAS EXTERNALIZED AND THE PATIENT TREATED WITH ANTIBIOTICS UNTIL THE CSF WAS STERILE. A NEW VPS WAS THEN IMPLANTED. THERE WERE NO FURTHER INFECTIONS IN THIS PATIENT DURING SUBSEQUENT FOLLOW-UP. A (B)(6) YEAR OLD FEMALE HAD A LATE SHUNT INFECTION OCCUR AFTER 9 MONTHS. THIS PATIENT SUFFERED FROM CROUZON SYNDROME AND UNDERWENT A LEFORT DISTRACTION AT THE AGE OF 11 YEARS AND AN ENDOSCOPIC TRANS-NASAL REPAIR OF A BASAL ENCEPHALOCELE AND EVD PLACEMENT AT THE AGE OF 13 YEARS. THE EVD WAS CONVERTED INTO A SHUNT AFTER 6 DAYS, SINCE THE PATIENT BECAME EVD DEPENDENT. NINE MONTHS LATER, THE PATIENT PRESENTED WITH A TRANS-NASAL CSF RHINORRHEA AND STREPTOCOCCUS PNEUMONIA MENINGITIS. THE LEAK WAS TREATED SURGICALLY, WHILE THE VP SHUNT WAS EXTERNALIZED AND THE PATIENT TREATED WITH ANTIBIOTICS. ONCE THE CSF CULTURES SHOWED NO BACTERIAL GROWTH, THE VPS WAS REINSERTED INTO THE ABDOMEN. A (B)(6) YEAR OLD MALE SHUNT PATIENT HAD AN UNDERLYING DIAGNOSIS OF BRAIN ABSCESS WHICH CAUSED HYDROCEPHALUS. THIS PATIENT EXPERIENCED A SHUNT INFECTION WHICH LED TO AN EVD INSERTION. A (B)(6) YEAR OLD FEMALE SHUNT PATIENT HAD AN UNDERLYING DIAGNOSIS OF CHIASMATIC HYPOTHALAMIC PILOCYTIC ASTROCYTOMA. THIS PATIENT EXPERIENCED A SHUNT INFECTION WHICH LED TO AN EVD INSERTION. A (B)(6) MONTH OLD FEMALE SHUNT PATIENT HAD AN UNDERLYING DIAGNOSIS OF INTRAVENTRICULAR HEMORRHAGE. THIS PATIENT EXPERIENCED A SHUNT INFECTION WHICH LED TO AN EVD INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791818 UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-V UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| R