BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE/SHUNT

    MDR report key: 8145281 · Received December 9, 2018

    Report

    Report Number
    2021898-2018-00555
    Event Type
    Injury
    Date Received
    December 9, 2018
    Date of Event
    January 17, 2007
    Report Date
    December 9, 2018
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PAOLA PERETTA, PAOLA RAGAZZI, CHRISTIAN F. CARLINO, PIERPAOLO GAGLINI & GIUSEPPE CINALLI. THE ROLE OF OMMAYA RESERVOIR AND ENDOSCOPIC THIRD VENTRICULOSTOMY IN THE MANAGEMENT OF POST-HEMORRHAGIC HYDROCEPHALUS OF PREMATURITY. CHILD'S NERVOUS SYSTEM 23 (2007). DOI 10.1007/S00381-006-0291-4. ABSTRACT OBJECTIVE THE AIM OF THIS STUDY IS TO RETROSPECTIVELY EVALUATE A SERIES OF CONSECUTIVE PATIENTS AFFECTED BY POSTHEMORRHAGIC HYDROCEPHALUS IN PREMATURITY, TREATED WITH AN IMPLANT OF AN OMMAYA RESERVOIR FOLLOWED BY VENTRICULOPERITONEAL (VP) SHUNT AND/OR ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) TO EVALUATE THE SAFETY AND EFFICACY OF THESE TREATMENT OPTIONS IN THE MANAGEMENT OF THE CONDITION. METHODS BETWEEN 2002 AND 2005, 18 CONSECUTIVE PREMATURE PATIENTS AFFECTED BY INTRA-VENTRICULAR HAEMORRHAGE (IVH) GRADES II TO IV, PRESENTING WITH PROGRESSIVE VENTRICULAR DILATATION, WERE OPERATED FOR IMPLANT OF AN INTRAVENTRICULAR CATHETER CONNECTED TO A SUB-CUTANEOUS OMMAYA RESERVOIR. CEREBROSPINAL FLUID WAS INTERMITTENTLY ASPIRATED PERCUTANEOUSLY BY THE RESERVOIR ACCORDING WITH THE CLINICAL REQUIREMENTS AND THE ECHOGRAPHIC FOLLOW-UP. THE PATIENTS WHO PRESENTED A PROGRESSION OF THE VENTRICULAR DILATATION WERE FINALLY OPERATED FOR VP SHUNT IMPLANT OR ETV ACCORDING WITH THE MRI FINDINGS. RESULTS ONE PATIENT HAD GRADE II, 5 HAD GRADE III, AND 12 HAD GRADE IV I VH. THE MEAN AGE AT IVH DIAGNOSIS WAS 5.2 DAYS; THE MEAN AGE AT RESERVOIR IMPLANT WAS 17.3 DAYS. THE OMMAYA RESERVOIR WAS PUNCTURED ON AN AVERAGE BASIS OF 11.4 TIMES PER PATIENT (RANGE 2¿25), AND THE MEAN INTERVAL BETWEEN ASPIRATIONS WAS 2.7 DAYS. THE MEAN CSF VOLUME PER TAP WAS 20 ML. ONE PATIENT DIED FOR PULMONARY COMPLICATIONS DURING THE STUDY PERIOD. OUT OF THE 17 SURVIVORS, 3 DID NOT DEVELOP PROGRESSIVE VENTRICULAR DILATATION, AND THEIR RESERVOIR WAS REMOVED; 14 DEVELOPED PROGRESSIVE HYDROCEPHALUS, 5 OF WHOM WERE IMPLANTED WITH A VP SHUNT AND 9 RECEIVED AN ETV. AMONGST THE FIVE SHUNTED PATIENTS, TWO WERE RE-ADMITTED FOR SHUNT MALFUNCTION AND HAD THEIR SHUNT REMOVED AFTER ETV AFTER 6.1 AND 20.5 MONTHS, RESPECTIVELY. AMONGST THE NINE PATIENTS WHO RECEIVED AN ETV, FIVE HAD TO BE RE-OPERATED FOR VP SHUNT IMPLANT AT AN AVERAGE INTERVAL OF 2.17 MONTHS (RANGE 9¿172 DAYS) BECAUSE OF INCREASING VENTRICULAR DILATATION. TWO OF THEM HAD A REDO THIRD VENTRICULOSTOMY WITH SHUNT REMOVAL AT 11 AND 25.1 MONTHS, RESPECTIVELY, AFTER INSERTION. THE FIRST WAS REIMPLANTED WITH A VP SHUNT 4 DAYS LATER; THE SECOND REMAINS SHUNT FREE. THEREFORE, AT THE END OF THE FOLLOW-UP PERIOD, 10 OUT OF 17 CHILDREN AFFECTED BY POSTHEMORRHAGIC HYDROCEPHALUS IN PREMATURITY WERE SHUNT FREE (59%). CONCLUSIONS THE COMBINATION OF OMMAYA RESERVOIR, VP SHUNT, AND THE AGGRESSIVE USE OF ETV AS A PRIMARY TREATMENT OR AS AN ALTERNATIVE TO SHUNT REVISION ALLOWED FOR A SIGNIFICANT REDUCTION OF SHUNT DEPENDENCY IN A TRADITIONALLY SHUNT-DEPENDENT POPULATION. FURTHER STUDIES ARE WARRANTED TO OPTIMISE THE ALGORITHM OF TREATMENT IN THESE PATIENTS. REPORTED EVENTS. 5. A 21 DAY OLD INFANT'S FIRST COMPLICATION WITH THE RESERVOIR WAS OBSTRUCTION LEADING TO A RESERVOIR REPLACEMENT. 6. A 21 DAY OLD INFANT'S FIRST COMPLICATION WITH THE RESERVOIR WAS MENINGITIS (STAPHYLOCOCCUS EPIDERMIDIS) AND REQUIRED AN EXTERNAL VENTRICULAR DRAINAGE. A VP SHUNT WAS EVENTUALLY INSERTED. 7. OUT OF 17 INFANTS, 3 PATIENTS (17.6%) RESOLVED HYDROCEPHALUS WITH OMMAYA TAPPING, WHEREAS 14 DEVELOPED A PROGRESSIVE VENTRICULAR DILATATION, 5 OF WHOM WERE IMPLANTED WITH A VP SHUNT AT AN AVERAGE AGE OF 2.4 MONTHS AND 9 RECEIVED AN ETV AT AN AVERAGE AGE OF 2.5 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984838 UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-V UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R