BEUDAMED
    FDA Adverse Event Death Summary report: N

    DELTA®

    MDR report key: 16363851 · Received February 13, 2023

    Report

    Report Number
    9612501-2023-00237
    Event Type
    Death
    Date Received
    February 13, 2023
    Date of Event
    January 25, 2023
    Report Date
    February 13, 2023
    Manufacturer
    COVIDIEN LLC
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PARTS HAVE BEEN RETURNED FOR ANALYSIS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ABSTRACT PURPOSE NEONATES WITH VENTRICULAR SHUNTS INSERTED FOR HYDROCEPHALUS FOLLOWING GERMINAL MATRIX HAEMORRHAGE (GMH) HAVE HIGH R ATES OF SHUNT REVISION. THE SHUNT VALVE PLAYS A KEY ROLE IN REGULATING THE FUNCTION OF THE SHUNT. IN THIS STUDY, WE AIM TO DETERMINE IF THE CHOICE OF FLOW-REGULATED OR PRESSURE-REGULATED VALVE USED IN THE INITIAL IMPLANTATION OF A SHUNT AFFECTS THE RATE OF SHUNT R EVISION. METHODS A RETROSPECTIVE COHORT COMPARISON STUDY WAS PERFORMED ON 34 NEONATES WITH HYDROCEPHALUS FOLLOWING GMH WHO UNDERWENT PLACEMENT OF A VENTRICULAR SHUNT AT THE QUEENSLAND CHILDREN¿S HOSPITAL FROM NOVEMBER 2014 TO JUNE 2020. THE PRIMARY OUTCOME EXAMINED WAS THE NEED FOR REVISION OR REPLACEMENT OF THE VENTRICULAR SHUNT AFTER SUCCESSFUL INITIAL PLACEMENT WITHIN 2 YEARS OF IMPLANTATION. THE SECONDARY OUTCOME EXAMINED WAS THE SURVIVAL TIME OF THE SHUNT. RESULTS 16 PATIENTS HAD PLACEMENT OF A FLOW-REGULATED VALVE, AND 18 PATIENTS HAD PLACEMENT OF A PRESSURE-REGULATED VALVE. 14 (87.5%) PATIENTS WITH FLOW-REGULATED VALVES REQUIRED REPLACEMENT DURING THE FOLLOW-UP PERIOD. 2 (18.18%) PATIENTS WITH A FIXED PRESSURE REGULATED UNDERWENT REVISION, WHILE 2 (28.57%) PROGRAMMABLE PRESSURE-REGULATED SHUNTS REQUIRED REVISION. PATIENTS THAT HAD A FLOW-REGULATED VALVE HAD A STATISTICALLY SIGNIFICANT HIGHER RATE OF REVISION COMPARED TO THOSE WHO HAD A PRESSURE-REGULATED VALVE, (87.5% FLOW VS 22.22% PRESSURE) WITH A P-VALUE OF DEATH EVENTS: ALL PATIENTS WITH HYDROCEPHALUS DUE TO GMH WERE EITHER GRADE 3 OR 4, 14 PATIENTS (41.17%) HAD A GRADE 4 GMH AND THE REMAINING 20 (58.82%) WERE GRADE 3. DURING THE FOLLOW-UP PERIOD, 2 PATIENTS PASSED AWAY, ONE WHO HAD AN OSVII VALVE INITIALLY PLACED AND ONE WHO HAD DELTA 1.5; IN BOTH CASES, THE SHUNT HAD FAILED AND BEEN REVISED PRIOR TO THEIR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387210 DELTA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG COVIDIEN LLC UNKNOWN-A

    Patients

    Seq Age Sex Outcome Treatment
    1 114 DA Male Death| R