BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE/SHUNT

    MDR report key: 8440934 · Received March 21, 2019

    Report

    Report Number
    2021898-2019-00121
    Event Type
    Injury
    Date Received
    March 21, 2019
    Date of Event
    January 10, 2019
    Report Date
    March 21, 2019
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: UNKNOWN-S, SERIAL/LOT #: UNKNOWN. 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

    KIMBERLY NGUYENA, CLAUDIA M. PROSPERO PONCEB, AROUCHA VICKERSB, AND ANDREW G. LEE. REVERSIBLE VISION LOSS DUE TO TRANSEPENDYMAL OEDEMA OF THE OPTIC APPARATUS SECONDARY TO VENTRICULOPERITONEAL SHUNT MALFUNCTION. NEURO-OPHTHALMOLOGY (2019). DOI: 10.1080/01658107.2019.1570280 ABSTRACT A (B)(6) YEAR-OLD MALE WITH A HISTORY OF PILOCYTIC ASTROCYTOMA STATUS POST-MULTIPLE VENTRICULOPERITONEAL SHUNT (VPS) REVISIONS PRESENTED WITH VISION LOSS, OCULAR MOTOR DEFICITS, AND HEADACHES. HIS SHUNT WAS REVISED BUT HE EXPERIENCED PERSISTENT VISION LOSS DESPITE RESOLUTION OF HIS HEADACHES AND DIPLOPIA. MAGNETIC RESONANCE IMAGING (MRI) OF THE HEAD REVEALED HYDROCEPHALUS AND T2 HYPERINTENSITY CONSISTENT WITH TRANSEPENDYMAL OEDEMA SURROUNDING THE MIDBRAIN, PONS, AND OPTIC APPARATUS. HIS SHUNT WAS AGAIN REVISED, BUT WAS COMPLICATED BY AN INFECTION THAT REQUIRED REMOVAL. HE UNDERWENT AN ENDOSCOPIC THIRD VENTRICULOSTOMY AND AN EXTERNAL VENTRICULAR DEVICE WAS TEMPORARILY PLACED. REPEAT MRI REVEALED MARKED IMPROVEMENT OF THE TRANSEPENDYMAL OEDEMA AND HYDROCEPHALUS. HIS VISION RETURNED TO BASELINE AND REMAINED STABLE AT 6-MONTHS FOLLOW-UP. REPORTED EVENTS. A (B)(6) YEAR-OLD MALE PRESENTED TO AN OPHTHALMOLOGIST AT AN OUTSIDE HOSPITAL WITH A 3-DAY HISTORY OF VISION LOSS, OCULAR MOTILITY DEFICITS, HEADACHES, NAUSEA, AND VOMITING. HIS PAST MEDICAL HISTORY INCLUDED CEREBELLAR PILOCYTIC ASTROCYTOMA STATUS-POST RESECTION AT AGE 3, WITH MULTIPLE VPS PLACEMENTS AND REVISIONS, MOST RECENTLY AT AGE 13. CIRCUMSTANCES SURROUNDING PREVIOUS VPS REVISIONS ARE UNKNOWN. SERIAL IMAGING STUDIES SHOWED STABLE POST-TREATMENT VENTRICULOMEGALY WITHOUT TRANSEPENDYMAL OEDEMA AND NO RECURRENT OR RESIDUAL CEREBELLAR ASTROCYTOMA. HIS PAST OCULAR HISTORY INCLUDED LONG STANDING PRIMARY POSITION AND GAZE EVOKED NYSTAGMUS WITH MILD AMBLYOPIA OD. HE HAS A PERSISTENT BILATERAL CRANIAL NERVE VI PALSY RESULTING IN A MILD ESOTROPIA THAT WORSENED SECONDARY TO VPS MALFUNCTION. HIS BASELINE VA IS 20/40 IN THE RIGHT EYE (OD) AND 20/25 IN THE LEFT EYE (OS). THE REMAINDER OF HIS HISTORY WAS UNREMARKABLE. OPHTHALMOLOGY EXAMINATION AT PRESENTATION REVEALED VA OF COUNT FINGERS (CF) IN BOTH EYES (OU) AND A SLOW AMPLITUDE UNIPLANAR HORIZONTAL NYSTAGMUS, MILDLY DAMPENED BY THE CHIN UP POSITION. 24¿2 HUMPHREY VISUAL FIELD (HVF) TESTING REVEALED A MEAN DEVIATION OF -26.26 DB AND AN INFERIOR ALTITUDINAL AND SUPERIOR PARACENTRAL DEFECT OD. THE RELIABILITY INDICES REVEALED FIXATION LOSSES OF 4/15 AND A FALSE POSITIVE RESPONSE ERROR OF 0% OD. TESTING IN THE LEFT EYE REVEALED A MEAN DEVIATION OF -16.27 DB AND A SUPERIOR ALTITUDINAL DEFECT. THE RELIABILITY INDICES REVEALED FIXATION LOSSES OF 0/0, A FALSE POSITIVE RESPONSE ERROR OF 3%, AND A FALSE NEGATIVE RATE OF 53% OS. HE WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL FOR FURTHER WORKUP. COMPUTED TOMOGRAPHY (CT) OF THE HEAD REVEALED MODERATE DILATION OF THE LATERAL AND THIRD VENTRICLES AND A VPS CATHETER. VPS MALFUNCTION WAS SUSPECTED AND THE VALVE WAS REPLACED WITH A PROGRAMMABLE STRATA II VALVE SET AT 1.5, AND THE DISTAL CATHETER WAS REPLACED. HIS HEADACHES AND DIPLOPIA IMPROVED; HOWEVER, VISION LOSS PERSISTED. HE WAS DISCHARGED WITH RECOMMENDED NEUROOPHTHALMOLOGY FOLLOW-UP. ON NEUROOPHTHALMOLOGIC EXAM ONE WEEK LATER, VA REMAINED 20/CF OU. HE WAS NOTED TO HAVE VERTICAL GAZE PALSY, CONVERGENCE-RETRACTION NYSTAGMUS, ¿SUN SETTING¿ EYES WITH BOTH EYES IN THE DOWNGAZE POSITION, AND BILATERAL ESOTROPIA OF 30 PRISM DIOPTERS (PD) THAT WAS WORSE THAN HIS BASELINE CHRONIC ESOTROPIA OF 20 PD. NO OPTIC NERVE OEDEMA WAS FOUND. CUP-TO-DISC RATIO WAS 0.3 OU. THERE WAS A MILD OPTIC ATROPHY INFERIORLY AND TEMPORALLY, AVERAGE RETINAL NERVE FIBRE LAYER THICKNESS ON OCT WAS 87 ¿M OD AND 84 ¿M OS. THE PATIENT WAS ADMITTED TO NEUROSURGERY. VPS SERIES SUGGESTED SHUNT DISCONNECTION/MALFUNCTION. MAGNETIC RESONANCE IMAGING (MRI) REVEALED VENTRICULOMEGALY AND ATYPICAL HYPERINTENSE T2 SIGNAL IN THE WHITE MATTER SURROUNDING THE MIDBRAIN, PONS, AND OPTIC APPARATUS. TRANSEPENDYMAL OEDEMA WAS PRESENT IN BOTH HEMISPHERES, EXTENDING INTO THE VISUAL PATHWAYS (FIGURE 1). DUE TO CONCERN FOR DEMYELINATING DISEASE, TESTING FOR SERUM ANTI-MYELIN OLIGODENDROCYTE GLYCOPROTEIN (MOG) ANTIBODIES WAS REQUESTED AND RETURNED POSITIVE WITH A TITRE OF 1:20 WHILE AQUAPORIN-4 ANTIBODIES WERE NEGATIVE. THE VPS WAS REPLACED. TWO DAYS POST-OPERATIVELY, VA MEASURED AT NEAR WAS 20/25 OU. 24¿2 HVF TESTING REVEALED A MEAN DEVIATION OF -8.16 DB OD AND -18.9 DB OS. UNFORTUNATELY, HE WAS READMITTED 6 DAYS AFTER WITH AN INFECTED SHUNT. CSF CULTURES GREW METHICILLIN- RESISTANT STAPHYLOCOCCUS AUREUS AND ANTIBIOTICS WERE ADMINISTERED. THE SHUNT WAS REMOVED. HE UNDERWENT AN ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) AND AN EXTERNAL VENTRICULAR DEVICE WAS TEMPORARILY PLACED, THEN REMOVED. A REPEATED MRI REVEALED MARKED RESOLUTION OF THE TRANSEPENDYMAL OEDEMA AND HYDROCEPHALUS. REPEAT TESTING FOR MOG ANTIBODIES WAS NEGATIVE. THE PATIENT¿S VISION RECOVERED TO BASELINE BY 6-MONTH FOLLOW-UP AFTER SHUNT REMOVAL. AT 12-MONTH FOLLOW-UP, THE PATIENT¿S VISION REMAINED STABLE AND THE MRI DEMONSTRATED COMPLETE RESOLUTION OF THE TRANSEPENDYMAL OEDEMA. 24¿2 VF WAS NORMALISED ON REPEAT TESTING AND REVEALED A MEAN DEVIATION OF -6.74 DB ODAND -3.79 DB OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234489 UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-V UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R