BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 7325146 · Received March 8, 2018

    Report

    Report Number
    2021898-2018-00129
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    November 6, 2017
    Report Date
    March 27, 2018
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MICHAEL S. GOLINKO, DANIELLE N. ATWOOD, EYLEM OCAL. SURGICAL MANAGEMENT OF CRANIOSYNOSTOSIS IN THE SETTING OF A VENTRICULAR SHUNT: A CASE SERIES AND TREATMENT ALGORITHM. CHILDS NERVOUS SYSTEM 34 (2018). DOI: 10.1007/S00381-017-3648-Y ABSTRACT PURPOSE CEREBROSPINAL FLUID DIVERSION VIA VENTRICULAR SHUNT IS A COMMON TREATMENT FOR HYDROCEPHALUS. CHANGE IN CRANIAL MORPHOLOGY ASSOCIATED WITH A SUTURAL FUSION HAS BEEN TERMED SHUNT-RELATED OR INDUCED CRANIOSYNOSTOSIS (SRC) OR CRANIOCEREBRAL DISPROPORTION (CCD). WE PRESENT A SERIES OF PATIENTS WITH SRC WHO UNDERWENT CRANIAL VAULT REMODELING (CVR) AND OUR TREATMENT ALGORITHM. METHODS THIRTEEN PATIENTS WERE RETROSPECTIVELY REVIEWED WHO HAD SRC AND CVR; 92%OF PATIENTS HAD A VENTRICULOPERITONEAL (VP) SHUNT PLACED FOR LARGELY INTRAVENTRICULAR HEMORRHAGE OF PREMATURITY (69% OF PATIENTS) AT A MEAN AGE OF 2.2 MONTHS. THE SHUNT REVISION RATE WAS 38.4%, AND 54% OF PATIENTS HAD A PROGRAMMABLE SHUNT PLACED INITIALLY. RESULTS THE MEAN AGE AT TIME OF CVR WAS 3.6 YEARS OLD. THE MOST COMMONLY AFFECTED SUTURES (CT CONFIRMED) WERE THE SAGITTAL AND CORONAL SUTURES, WITH THREE PATIENTS EXHIBITING PANCRANIOSYNOSTOSIS. THE MEAN TIME FROM PLACEMENT OF THE SHUNT TO CT EVIDENCE OF SUTURAL FUSION WAS 2.0 YEARS. ABNORMAL HEAD SHAPE WAS NOTED IN ALL 13 PATIENTS; 11 OF THESE ALSO HAD EITHER CHRONIC HEADACHES, PAPILLEDEMA, SEIZURES, OR BEHAVIORAL CHANGES IN THE SETTING OF FUNCTIONAL SHUNT. MEAN FOLLOW-UP AFTER THE INITIAL CVR WAS 3.3 YEARS. NO SHUNT INFECTIONS WERE ATTRIBUTED TO THE CVR. THE FAMILIES OF ALL PATIENTS WERE CONTACTED AND REPORTED IMPROVEMENT IN HEAD SHAPE WITH 60% OF FAMILIES REPORTING IMPROVEMENT IN BEHAVIOR, 75% REPORTED IMPROVEMENT IN HEADACHES, AND 40% REPORTED DECREASE IN SEIZURE FREQUENCY OR INTENSITY. SHUNT SETTING OR TYPE WAS NOT ROUTINELY CHANGED AFTER CVR. CONCLUSIONS OUR THRESHOLD FOR CVR IN SRC IS MET WHEN SHUNT MALFUNCTION HAS BEEN RULED OUT AND THERE ARE (1) RADIOGRAPHIC EVIDENCE OF CRA NIOSYNOSTOSIS, (2) SIGNS OF INCREASED ICP CLINICALLY OR RADIOGRAPHICALLY, AND (3) CRANIAL DYSMORPHISM, I.E., DOLICHOCEPHALY. THE MAJORITY OF CASES OF SRC RESULT IN IMPROVED CRANIAL MORPHOLOGY IN ADDITION TO SOME ABATEMENT OF THE SYMPTOMS OF INCREASED INTRACRANIAL PRESSURE. EARLY INVOLVEMENT OF AN EXPERIENCED CRANIOFACIAL/NEUROSURGICAL TEAM COULD ALLOW FOR EARLY DIAGNOSIS AND INTERVENTION WHICH MAY PREVENT PROGRESSION TO MORE SEVERE DEFORMITIES. SRC IS A COMPLEX ENTITY, WITH MULTIPLE ETIOLOGIES, AND A FUTURE STUDY IS NEEDED. REPORTED EVENTS. A MALE WHO WAS IMPLANTED FOR INTRAVENTRICULAR HEMORRHAGE (IVH) HAD SIX REVISIONS STARTING 4 YEARS FOLLOWING CVR DUE TO PROXIMAL MALFUNCTIONS. HIS SHUNT BEGAN AT SETTING OF 2.0, BUT THEN WAS LOWERED TO 1.0, APPROXIMATELY 4 MONTHS PRIOR TO CVR BECAUSE OF DILATED VENTRICLES, VOMITING, AND IRRITABILITY. NO CHANGE IN THE SETTING WAS MADE AFTER CVR. THE PATIENT HAD BEEN EXPERIENCING THE FOLLOWING ADVERSE SYMPTOMS ASSOCIATED TO THE SETTING OF THE FUNCTIONAL SHUNT: ABNORMAL HEAD SHAPE AND HEADACHES. A FEMALE WHO WAS IMPLANTED FOR LISSENCEPHALY STARTED AT A 1.5 SETTING BUT THEN PRESENTED WITH SEIZURE-LIKE ACTIVITY, CHANGE IN MENTAL STATUS, AND A CT REVEALING CHRONIC SUBDURAL HEMATOMA. TO ATTENUATE THE HEMATOMA, THE SETTING WAS INCREASED TO 2.0,6 MONTHS PRIOR TO CVR AND NOT CHANGED AFTERWARDS. THE PATIENT ALSO HAD BEEN EXPERIENCING THE FOLLOWING ADVERSE SYMPTOMS ASSOCIATED TO THE SETTING OF THE FUNCTIONAL SHUNT: ABNORMAL HEAD SHAPE. A FEMALE WHO WAS IMPLANTED FOR INTRAVENTRICULAR HEMORRHAGE (IVH) PRESENTED TO THE CENTER AT 5 MONTHS OF AGE WITH AN INITIAL SETTING OF 0.5, WHICH WAS INCREASED TO 1.5 AFTER A CT SCAN REVEALED COLLAPSE OF THE CEREBRAL MANTLE AND SUBDURAL HYGROMA. THE SHUNT SETTING WAS NOT ADJUSTED AFTER SURGERY. THE PATIENT HAD BEEN EXPERIENCING THE FOLLOWING ADVERSE SYMPTOMS ASSOCIATED TO THE SETTING OF THE FUNCTIONAL SHUNT: ABNORMAL HEAD SHAPE, BEHAVIORAL CHANGES, HEADACHES, AND SEIZURES. A MALE WHO WAS IMPLANTED FOR INTRAVENTRICULAR HEMORRHAGE (IVH) HAD PROGRAMMABLE VALVE SET AT 2.0 WHICH WAS NOT ADJUSTED AT ANY POINT BUT STILL HAD SLIT-LIKE VENTRICLES. THE PATIENT HAD BEEN EXPERIENCING THE FOLLOWING ADVERSE SYMPTOMS ASSOCIATED TO THE SETTING OF THE FUNCTIONAL SHUNT: ABNORMAL HEAD SHAPE, HEADACHES, AND SEIZURES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO FURTHER INFORMATION BECAUSE THESE WERE PATIENTS WHO DID NOT RECEIVE A MEDTRONIC SHUNT FOR THE SURGERY DESCRIBED IN THE LITERATURE ARTICLE. IT IS UNCLEAR THE INVOLVEMENT OF THE MEDTRONIC DEVICES SINCE IN THE LITERATURE ARTICLE, THE PATIENTS HAD MEDTRONIC DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165966 UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R