BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRATA®

    MDR report key: 14251655 · Received April 29, 2022

    Report

    Report Number
    9612501-2022-00694
    Event Type
    Death
    Date Received
    April 29, 2022
    Date of Event
    October 29, 2020
    Report Date
    April 29, 2022
    Manufacturer
    COVIDIEN LLC
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    GALARZA, M., ETUS, E., SOSA, F., ARGAÑARAZ, R., MANTESE, B., GAZZERI, R., MONTOYA, C.G., ROSA, P., GUERRERO, A.L., CHABAN, G., GIMÉNEZ, A., AMIGÓ, J.M. FLOW VENTRICULAR CATHETERS FOR SHUNTED HYDROCEPHALUS: INITIAL CLINICAL RESULTS. CHILD'S NERVOUS SYSTEM 2021. (37) 903¿911. HTTPS://DOI.ORG/10.1007/S00381-020-04941-8. BACKGROUND THE NON-HOMOGENOUS FLOW OF THE CEREBROSPINAL FLUID WITHIN THE VENTRICULAR CATHETER IS ONE OF THE CAUSATIVE FACTORS IN SHUNT OBSTRUCTIONS DURING THE TREATMENT OF HYDROCEPHALUS. PREVIOUSLY, WE STUDIED THE FLOW IN VENTRICULAR CATHETERS UNDER THE STEADY AND PULSATILE BOUNDARY CONDITIONS BY MEANS OF COMPUTATIONAL FLUID DYNAMICS (CFD) IN THREE-DIMENSIONAL PARADIGMS. SUBSEQUENTLY, SEVERAL CATHETER DESIGNS WITH HOMOGENEOUS FLOW PATTERNS WERE DEVELOPED OUT OF WHICH ONE PROTOTYPE WAS CHOSEN AFTER A VALIDATION STUDY. OBJECTIVE TO TEST THE EFFECTIVENESS OF THE FLOW VENTRICULAR CATHETER IN A PROSPECTIVE, MULTICENTER, COMPARATIVE STUDY. METHODS ELIGIBLE CENTERS WERE THREE PEDIATRIC HOSPITALS: TWO WITH SOLE ADULT PRACTICE AND ONE A MIXED PEDIATRIC-ADULT. STANDARD SILICONE MATERIAL WAS USED TO DEVELOP A PARAMETRIC CATHETER MODEL WITH HOMOGENOUS FLOW CHARACTERISTICS. THE FLOW CATHETERS WERE INSERTED IN PEDIATRIC (N = 30) AND ADULT (N = 10) PATIENTS WITH ALL TYPES OF HYDROCEPHALUS. SIMULTANEOUSLY, REGULAR VENTRICULAR CATHETERS WERE INSERTED IN ANOTHER 43 CONTROL PATIENTS IN THE PARTICIPATING CENTERS. CATHETER POSITIONING WAS STANDARDIZED ACCORDING TO THE SCHAUMANN AND THOMALE CLASSIFICATION. RESULTS ALL VENTRICULAR CATHETERS HAD A CEPHALAD GRADE I OR II POSITIONING, AND CAUDALLY, ITS EXTENSION HAD A PERITONEAL LOCATION. PROGRAMMABLE VALVES WERE UTILIZED IN 70% AND ANTISIPHON DEVICES IN 20% OF THE CASES. REGULAR DIFFERENTIAL PRESSURE VALVES WERE UTILIZED IN THE REMAINING. NO CASE OF FLOW CATHETER OBSTRUCTION WAS IDENTIFIED DURING A MEAN FOLLOW-UP PERIOD OF 2 YEARS AT THE TIME OF THIS WRITING. THERE WERE FOUR CATHETER OBSTRUCTIONS IN THE CONTROL COHORT, ALL PEDIATRIC CASES, DURING THE FIRST YEAR. SHUNT INFECTIONS OCCURRED IN TWO CASES IN THE CONTROL GROUP, WHILE THERE WAS ONE RECURRENT CASE OF ADULT VENTRICULITIS IN THE FLOW CATHETER GROUP. CONCLUSIONS THIS PROTOTYPE MODEL REPRESENTS THE NEXT GENERATION OF VENTRICULAR CATHETERS WITH A HOMOGENEOUS FLOW PATTERN. THE FLOW CATHETER CAN BE INSERTED SAFELY IN HYDROCEPHALIC PATIENTS, AND THIS PRELIMINARY PROSPECTIVE COMPARATIVE STUDY SHOWED A POSSIBLE OBSTRUCTION-FREE FUNCTIONALITY. REPORTED EVENTS: ONE PATIENT WITH POSTHEMORRHAGIC (SAH) HYDROCEPHALUS, REBLED FROM AN INTRACRANIAL ANEURYSM AND DIED 2 MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213917 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG COVIDIEN LLC UNKNOWN-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death