BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN VALVE/SHUNT

    MDR report key: 22017734 · Received May 14, 2025

    Report

    Report Number
    9612501-2025-01283
    Event Type
    Death
    Date Received
    May 14, 2025
    Date of Event
    March 28, 2025
    Report Date
    May 14, 2025
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MICHAEL J. STUART, ANNABELLE M. HARBISON, TIMOTHY RUDER, JOSHUA HACKNEY, NORMAN MA, ROBERT A. J. CAMPBELL, AMELIA J. JARDIM, AND LIAM G. COULTHARD. THE RISKS OF OMITTING ROUTINE POSTOPERATIVE IMAGING AFTER INSERTION OF NEW VENTRICULAR SHUNTS IN CHILDREN: A 10-YEAR RETROSPECTIVE COHORT STUDY. JOURNAL OF NEUROSURGERY PEDIATRICS (2025). DOI: 10.3171/2024.12.PEDS24496. OBJECTIVE VENTRICULOPERITONEAL SHUNT INSERTION IS THE PRIMARY TREATMENT FOR PEDIATRIC HYDROCEPHALUS AND IS ONE OF THE MOST COMMON PROCEDURES PERFORMED IN PEDIATRIC NEUROSURGERY. HOWEVER, THE VALUE OF ROUTINE POSTOPERATIVE IMAGING REMAINS CONTROVERSIAL. ALTHOUGH SOME EVIDENCE SUGGESTS THAT ROUTINE POSTOPERATIVE IMAGING PROVIDES A LOW YIELD AFTER SHUNT REVISION, ITS ROLE FOLLOWING INITIAL SHUNT INSERTION IN CHILDREN HAS NOT BEEN REPORTED. ADDITIONALLY, THE ROLE OF ROUTINE POSTOPERATIVE IMAGING AS A BASELINE STUDY IN ALTERING THE RATE OF LONGER-TERM SHUNT REVISION RATES REMAINS UNEXPLORED. METHODS A RETROSPECTIVE REVIEW WAS CONDUCTED USING A PROSPECTIVELY MAINTAINED SURGICAL DATABASE, ENCOMPASSING 10 YEARS OF CONSECUTIVE CASES FROM A QUATERNARY PEDIATRIC NEUROSURGICAL CENTER SERVING A POPULATION OF 5.3 MILLION. STATEWIDE ELECTRONIC MEDICAL RECORDS INCLUDING IMAGING AND MORTALITY DATA WERE REVIEWED. ONLY CASES INVOLVING THE INSERTION OF A NEW VENTRICULAR SHUNT SYSTEM WERE INCLUDED. BASED ON LONGSTANDING PHYSICIAN PREFERENCES, APPROXIMATELY HALF THE NEUROSURGEONS IN THE DEPARTMENT DID NOT ROUTINELY PERFORM POSTOPERATIVE IMAGING DURING THE STUDY PERIOD. THE PRIMARY OUTCOMES WERE SHUNT-RELATED MORTALITY DURING THE STUDY PERIOD, SHUNT REVISION OR MORTALITY WITHIN 7 DAYS OF SURGERY, OR HOSPITAL DISCHARGE, WITH TIME TO FIRST REVISION AS A SECONDARY OUTCOME. RESULTS DURING THE STUDY PERIOD 1485 SHUNT PROCEDURES WERE PERFORMED, OF WHICH 427 INVOLVED THE PLACEMENT OF A NEW VENTRICULOPERITONEAL SHUNT SYSTEM. THE MEAN AGE OF THE PATIENTS WAS 5.2 YEARS (RANGE PREMATURE TO 18 YEARS). A TOTAL OF 206/427 (48%) UNDERWENT ROUTINE POSTOPERATIVE IMAGING WITH MR OR CT, AND 153/427 (36%) UNDERWENT ROUTINE POSTOPERATIVE SHUNT SERIES RADIOGRAPHS. DURING THE STUDY PERIOD, 2 ABDOMINAL RADIOGRAPHS IDENTIFIED PREPERITONEAL PLACEMENT; HOWEVER, IN BOTH CASES A SYMPTOMATIC SUBCUTANEOUS FLUID COLLECTION WAS PRESENT (2/427, 0.5%). POSTOPERATIVE CT OR MR STUDIES IDENTIFIED 1 CASE OF EXTRAVENTRICULAR CATHETER PLACEMENT AND 5 CASES OF A KINK ADJACENT TO THE VALVE (6/427, 1.4%), OF WHICH 4 CASES WERE DETECTED ON ROUTINE IMAGING (4/427, 0.9%). NO SIGNIFICANT DIFFERENCES WERE DETECTED BETWEEN PATIENTS WITH OR WITHOUT IMAGING IN 7-DAY POSTOPERATIVE (14 [7%] VS 8 [4%], P = 0.25) OR 7-DAY POSTDISCHARGE (2 [1%] VS 1 [<(><<)> 1%], P = 0.96) RATES OF NONINFECTIVE SHUNT REVISION, SHUNT-RELATED MORTALITY (4 [2%] VS 5 [2%], RESPECTIVELY, P = 0.8) OR KAPLAN-MEIER LONG-TERM SHUNT SURVIVAL CURVES (ALL P > 0.05). CONCLUSIONS ROUTINE POSTOPERATIVE IMAGING AFTER PEDIATRIC SHUNT INSERTION RARELY IDENTIFIES CLINICALLY SIGNIFICANT ISSUES, AND CONSI DERATION COULD BE GIVEN TO ITS OMISSION. REPORTED EVENTS: - NO STATISTICALLY SIGNIFICANT DIFFERENCES IN SHUNT-RELATED MORTALITY DURING THE STUDY PERIOD OCCURRED IN THE GROUPS WHO DID OR DID NOT UNDERGO ROUTINE POSTOPERATIVE AXIAL IMAGING (4 [2%] VS 5 [2%], P = 0.8) OR RADIOGRAPHS (2 [1%] VS 7 [3%], P = 0.39). IT WAS INDICATED THAT MEDTRONIC DELTA AND STRATA VALVES WERE USED IN THE LITERATURE ARTICLE, HOWEVER, THE ARTICLE DOES NOT INDICATED WHICH FAILURES AND ADVERSE EVENTS ARE ASSOCIATED WITH WHAT VALVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216335 UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA UNKNOWN-V UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death