BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HAKIM PRECISION VALVE

    MDR report key: 6431940 · Received March 24, 2017

    Report

    Report Number
    1226348-2017-10181
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    February 1, 2017
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION. HOWEVER, MULTIPLE ATTEMPTS TO OBTAIN THE SAMPLE WERE NOT SUCCESSFUL. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT OR PRODUCT NUMBER INFORMATION WAS PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. COMPLAINT WILL BE CLOSED AT THIS TIME AS 'NO COMPLAINT SAMPLE RETURNED TO CODMAN FOR EVALUATION'. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE, UDI UNAVAILABLE. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IN THE FLASH PRESENTATION FP094 AT ¿25TH CONGRESS OF THE EUROPEAN SOCIETY FOR PEDIATRIC NEUROSURGERY (ESPN) PARIS-FRANCE, 8-11 MAY 2016¿ TITLED ¿SURVIVAL OF GRAVITATIONAL VERSUS TRADITIONAL NONGRAVITATIONAL VALVES AFTER PRIMARY VENTRICULOPERITONEAL SHUNT INSERTION IN CHILDREN: A RETROSPECTIVE COHORT STUDY ¿, PUBLISHED CHILDS NERV SYST (2016) 32:905¿1012 DOI 10.1007/S00381-016-3044-Z, IT WAS REPORTED THAT 55 SHUNT FAILURES POST IMPLANTATION OF UNKNOWN CODMAN HAKIM PRECISION VALVES. PER THE ARTICLE: ¿INTRODUCTION: GRAVITATIONAL VALVES -DESIGNED TO REDUCE OVERDRAINAGE BY PREVENTING SIPHONING- ARE INCREASINGLY BEING USED FOR PRIMARY SHUNTS IN CHILDREN. THIS LONG-TERM THEORETICAL ADVANTAGE IS TEMPERED BY THE SUSPICION THAT MORE COMPLEX VALVE DESIGNS ARE MORE PRONE TO EARLY FAILURE. METHODS: RETROSPECTIVE COHORT STUDY, EXAMINING ALL PRIMARY SHUNTS -EITHER GRAVITATIONAL VALVE (GV; MIETHKE PAEDIGAV) OR NON-GRAVITATIONAL VALVE (NGV; CODMAN PRECISION) INSERTED AT OUR INSTITUTION DURING THE STUDY PERIOD 2007-2014. EARLY FAILURE WAS DEFINED AS NEED FOR SHUNT REVISION WITHIN 30 DAYS OF PRIMARY SURGERY. LATE FAILURE WAS DEFINED AS NEED FOR SHUNT REVISION AT ANY POINT FOLLOWING 30 DAYS. CHI SQUARE STATISTICAL ANALYSIS WAS USED TO COMPARE GROUPS. RESULTS: 207 PRIMARY SHUNTS WERE INSERTED DURING THE STUDY PERIOD -36 GV AND 171 NGV. MEAN AGE OF THE GV GROUP WAS 262 DAYS AGAINST 783 DAYS IN NGV GROUP. THE DIAGNOSIS PROFILE DIFFERED BETWEEN THE 2 GROUPS, WITH POST-HEMORRHAGIC AND DYSRAPHISM-ASSOCIATED HYDROCEPHALUS PROPORTIONALLY MORE COMMON IN THE GV GROUP AND TUMOR-ASSOCIATED HYDROCEPHALUS MORE COMMON IN NGV GROUP. THERE WERE 5 EARLY FAILURES IN THE GV GROUP AND 10 IN THE NGV GROUP. FOR LATE FAILURES, THERE WERE 4 EVENTS IN THE GV GROUP WITH 45 IN THE NGV GROUP. CONCLUSIONS: THE OVERALL 1 YEAR SURVIVAL WAS ALMOST IDENTICAL BETWEEN THE 2 GROUPS, ALTHOUGH THERE WAS A TREND FOR MORE EARLY FAILURES IN THE GV GROUP WHICH WAS BALANCED BY LESS LATE FAILURES. IN LINE WITH PREVIOUS STUDIES, THERE IS LITTLE EVIDENCE CURRENTLY TO SUGGEST SUPERIORITY OF ONE VALVE CHOICE OVER ANOTHER FOR PRIMARY SHUNTS IN CHILDREN.¿ AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213346 UNK HAKIM PRECISION VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention