BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CATHETER

    MDR report key: 8188409 · Received December 21, 2018

    Report

    Report Number
    2021898-2018-00579
    Event Type
    Injury
    Date Received
    December 21, 2018
    Report Date
    December 20, 2018
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MICHAEL KIM, ILYA RYBKIN, HARRISON SMITH, JARED COOPER, MICHAEL TOBIAS. BONE OVERGROWTH CAUSING PROXIMAL VENTRICULOPERITONEAL SHUNT MALFUNCTION. WORLD NEUROSURGERY 121 (2019). DOI: 10.1016/J.WNEU.2018.10.030 BACKGROUND: HYDROCEPHALUS IS AN INTERNATIONAL DISEASE PROCESS THAT IS COMMONLY TREATED SURGICALLY WITH A VENTRICULOPERITONEAL SHUNT. THIS DEVICE MAY BE PRONE TO MALFUNCTION, MOST COMMONLY FROM OBSTRUCTION, DISCONNECTION, OR INFECTION. CASE DESCRIPTION: A (B)(6) YEAR-OLD FEMALE WITH HYDROCEPHALUS AND A VENTRICULOPERITONEAL SHUNT PRESENTED WITH ALTERED MENTAL STATUS AND IMAGING CONCERNING FOR A SHUNT MALFUNCTION. INTRAOPERATIVELY, SHE WAS FOUND TO HAVE BONE GROWING OVER AND COMPRESSING THE PROXIMAL OCCLUDER OF THE SHUNT VALVE, CAUSING A MECHANICAL OBSTRUCTION. REMOVAL OF THE BONE ALLOWED FOR EGRESS OF CEREBROSPINAL FLUID AND RETURN OF PROPER SHUNT FUNCTION. THE PATIENT DID WELL POSTOPERATIVELY. CONCLUSION: HYDROCEPHALUS, VENTRICULOPERITONEAL SHUNTS, AND SHUNT REVISIONS REPRESENT A SIGNIFICANT HEALTH BURDEN AND COST. HERE WE PRESENT AN UNUSUAL CAUSE OF A SHUNT MALFUNCTION CAUSED BY BONY OVERGROWTH. REPORTED EVENTS. THE PATIENT IS A (B)(6) YEAR-OLD FEMALE WITH A MEDICAL HISTORY OF CEREBRAL PALSY, MENTAL RETARDATION, SEIZURES, AND CONGENITAL HYDROCEPHALUS REQUIRING A VPS PLACED AT BIRTH WHO PRESENTED TO THE EMERGENCY DEPARTMENT FROM HER GROUP HOME WITH ALTERED MENTAL STATUS. SHE HAD BEEN LESS PARTICIPATORY IN GROUP ACTIVITIES OVER THE PREVIOUS WEEK AND HAD DECREASED ORAL INTAKE. SHE HAD NO NAUSEA OR LETHARGY. THIS PERSONALITY CHANGE PROMPTED CRANIAL IMAGING, FIRST WITH A COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD, WHICH REVEALED INCREASED DILATATION OF HER VENTRICLES, CONCERNING FOR A VPS MALFUNCTION. THE SHUNT RESERVOIR WAS THEN TAPPED, REVEALING SLUGGISH PROXIMAL FLOW WITH A LOW OPENING PRESSURE AND GOOD DISTAL FLOW. GIVEN HER WORSENING NEUROLOGIC EXAMINATION AND CT RESULTS, SHE WAS TAKEN TO THE OPERATING ROOM FOR EXPLORATION OF HER VPS. UPON EXPOSURE OF THE SHUNT VALVE, BONY OVERGROWTH WAS IMMEDIATELY EVIDENT OVER THE PROXIMAL CATHETER AND THE PROXIMAL OCCLUDER OF THE LOW PRESSURE VALVE (MEDTRONIC, MINNEAPOLIS, MINNESOTA). THE SHUNT WAS ONCE AGAIN TAPPED WITH SIMILAR RESULTS AS BEFORE. THE DISTAL CATHETER WAS DISCONNECTED FROM THE VALVE. IT WAS NOTED TO FLUSH EASILY, CONFIRMING ITS PATENCY. HOWEVER, NO FLOW OF CSF WAS NOTED FROM THE VALVE. AS THE BONE OVER THE PROXIMAL OCCLUDER WAS REMOVED, CSF BEGAN TO SLUGGISHLY EGRESS FROM THE VALVE. THE PROXIMAL CATHETER WAS THEN EXAMINED WITH THE NEUROPEN ENDOSCOPE (MEDTRONIC), AND DEBRIS WAS VISUALIZED WITHIN IT, CONFIRMING AN ADDITIONAL PARTIAL OCCLUSION. THE PROXIMAL CATHETER WAS THEN REPLACED. THE PATIENT DID WELL POSTOPERATIVELY, AND A REPEAT CT SCAN OF THE HEAD SHOWED AN INTERVAL REDUCTION IN THE SIZE OF THE VENTRICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027959 UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R