BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 14458521 · Received May 20, 2022

    Report

    Report Number
    1723170-2022-00775
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    October 8, 2021
    Report Date
    May 19, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENTS IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURE DATE IS DEPENDENT ON THE DEVICE LOT/SERIAL NUMBER, THEREFORE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CITATION: CLAUDIA L. CRAVEN, MSC, MRCS, PAUL GISSEN, PHD, FRCPCH, REBECCA BOWER, LAURA LEE, KRISTIAN AQUILINA, MD, FRCS(SN), AND DOMINIC N. P. THOMPSON. A SURVIVAL ANALYSIS OF VENTRICULAR ACCESS DEVICES FOR DELIVERY OF CERLIPONASE ALFA. JNS PEDIATRICS. DOI: 10.3171/2021.7.PEDS21129. ABSTRACT: OBJECTIVE LATE INFANTILE NEURONAL CEROID LIPOFUSCINOSIS TYPE 2 (CLN2) IS A RARE AUTOSOMAL RECESSIVE DISEASE CAUSED BY TRIPEPTIDYL PEPTIDASE 1 ENZYME DEFICIENCY. AT THE AUTHORS¿ CENTER, THE MEDICATION CERLIPONASE ALFA IS ADMINISTERED EVERY 2 WEEKS VIA THE INTRACEREBROVENTRICULAR (ICV) ROUTE. THIS REQUIRES THE PLACEMENT OF A VENTRICULAR ACCESS DEVICE (VAD) OR RESERVOIR AND FREQUENT PERCUTANEOUS PUNCTURES OF THIS DEVICE OVER THE CHILD¿S LIFETIME. IN THIS STUDY, THE AUTHORS AUDITED THE LONGEVITY AND SURVIVAL OF THESE VADS AND EXAMINED THE CAUSES OF DEVICE FAILURE. METHODS A SINGLE-CENTER SURVIVAL ANALYSIS OF VAD INSERTIONS AND REVISIONS (JANUARY 2014 THROUGH JUNE 2020) WAS CONDUCTED. ALL CHILDREN RECEIVED CERLIPONASE ALFA INFUSIONS THROUGH A VAD. PATIENT CHARACTERISTICS AND COMPLICATIONS WERE DETERMINED FROM A PROSPECTIVELY MAINTAINED SURGICAL DATABASE AND PATIENT RECORDS. FOR THE VAD SURVIVAL ANALYSIS, THE DEFINED ENDPOINT WAS WHEN THE DEVICE WAS REMOVED OR CHANGED. RESERVOIR SURVIVAL WAS ASSESSED USING KAPLAN- MEIER CURVES AND THE LOG-RANK (COX-MANTEL) TEST. RESULTS A TOTAL OF 17 PATIENTS HAD VADS INSERTED FOR DRUG DELIVERY; MEDIAN (RANGE) AGE AT FIRST SURGERY WAS 4 YEARS 4 MONTHS (1 YEAR 8 MONTHS TO 15 YEARS). TWENTY-SIX VAD OPERATIONS (17 PRIMARY INSERTIONS AND 9 REVISIONS) WERE REQUIRED AMONG THESE 17 PATIENTS. TWELVE VAD OPERATIONS HAD AN ASSOCIATED COMPLICATION, INCLUDING CSF INFECTION (N = 6) WITH PROPIONIBACTERIUM AND STAPHYLOCOCCUS SPECIES BEING THE MOST PREVALENT ORGANISMS, SIGNIFICANT SURGICAL SITE SWELLING PREVENTING INFUSION (N = 3), LEAKAGE/WOUND BREAKDOWN (N = 2), AND CATHETER OBSTRUCTION (N = 1). THERE WERE NO COMPLICATIONS OR DEATHS ASSOCIATED WITH VAD INSERTION. THE MEDIAN (INTERQUARTILE RANGE) NUMBER OF PUNCTURES WAS 59.5 (7.5¿82.0) FOR UNREVISED VADS (N = 17)VERSUS 2 (6¿87.5) FOR REVISED VADS (N = 9) (P = 0.70). THE MEDIAN SURVIVAL WAS 301 DAYS FOR REVISIONAL RESERVOIRS (N = 9) VERSUS 2317 DAYS FOR PRIMARY INSERTED RESERVOIRS (N = 17) (P = 0.019). CONCLUSIONS IN THE CONTEXT OF THE CURRENT INTEREST IN INTRATHECAL DRUG DELIVERY FOR RARE METABOLIC DISORDERS, THE NEED FOR VADS IS LIKELY TO INCREASE. AUDITING THE MEDIUM- TO LONG-TERM OUTCOMES ASSOCIATED WITH THESE DEVICES WILL HOPEFULLY RESULT IN THEIR WIDER APPLICATION AND MAY HAVE POTENTIAL IMPLICATIONS ON THE DEVELOPMENT OF NEW VAD TECHNOLOGIES. THESE RESULTS COULD ALSO BE USED TO COUNSEL PARENTS PRIOR TO COMMENCEMENT OF THERAPY AND VAD IMPLANTATION. REPORTED EVENTS: TWELVE OF THE 26 INSERTED VADS HAD A COMPLICATION. 9 OF WHICH REQUIRED REVISION. SIX OF THE VADS RESULTED IN A CEREBROSPINAL FLUID (CSF) INFECTION. THREE OF THE VADS RESULTED IN SIGNIFICANT SURGICAL SITE SWELLING PREVENTING INFUSION. TWO UNITS HAD LEAKAGE/WOUND BREAKAGE. ONE INSTANCE OF CATHETER OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520266 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 MO Female Required Intervention