BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRATA®

    MDR report key: 14167980 · Received April 21, 2022

    Report

    Report Number
    9612501-2022-00621
    Event Type
    Death
    Date Received
    April 21, 2022
    Date of Event
    September 27, 2021
    Report Date
    April 21, 2022
    Manufacturer
    COVIDIEN LLC
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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 PATIENT 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. 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

    MANSOOR, N., SOLHEIM, O., FREDRIKSLI, O.A., GULATI, A. SHUNT COMPLICATIONS AND REVISIONS IN CHILDREN: A RETROSPECTIVE SINGLE INSTITUTION STUDY. BRAIN BEHAVIOR. 2021. 11 (E2390) 1-8. DOI: 10.1002/BRB3.2390. ABSTRACT INTRODUCTION: SHUNT SURGERY IN CHILDREN IS ASSOCIATED WITH HIGH REVISION AND COMPLICATION RATES. WE INVESTIGATED REVISION RATES AND POSTOPERATIVE COMPLICATIONS TO SPECIFY CURRENT CHALLENGES ASSOCIATED WITH PEDIATRIC SHUNT SURGERY. METHODS: ALL PATIENTS AGED (B)(6) ADMITTED TO ST. OLAVS UNIVERSITY HOSPITAL, NORWAY, FROM JANUARY 2008 THROUGH DECEMBER 2017, WHO UNDERWENT PRIMARY SHUNT INSERTIONS, WERE REVIEWED. FOLLOW-UP RANGED FROM 1 TO 10 YEARS. VENTRICULOPERITONEAL, CYSTOPERITONEAL, AND VENTRICULOATRIAL SHUNTS WERE INCLUDED. ALL SUBSEQUENT SHUNT REVISIONS AND 30-DAY POSTOPERATIVE COMPLICATION RATES WERE REGISTERED. RESULTS: 81 PATIENTS UNDERWENT 206 SURGERIES IN THE STUDY PERIOD. 47 PATIENTS (58%) REQUIRED MINIMUM ONE REVISION DURING FOLLOW-UP. IN 14 (29.8%), THE FIRST REVISION WAS DUE TO THE MISPLACEMENT OF HARDWARE. PROXIMAL OCCLUSION WAS THE MOST COMMON CAUSE OF REVISION (30.4%), FOLLOWED BY MISPLACEMENT (18.5%) AND INFECTION (9.6%). YOUNG AGE AND MMC WERE ASSOCIATED WITH REVISION SURGERY IN A UNIVARIABLE ANALYSIS, BUT WERE NOT SIGNIFICANT IN MULTIVARIABLE ANALYSES. CONGENITAL HYDROCEPHALUS WAS ASSOCIATED WITH INFECTION (P = .028). IN APPROXIMATELY 30% OF PROCEDURES, COMPLICATIONS OCCURRED WITHIN 30 DAYS POSTOPERATIVELY, THE MOST COMMON BEING REVISION SURGERY. IN APPROXIMATELY 5% OF THE PROCEDURES, MEDICAL COMPLICATIONS OCCURRED. CONCLUSION: CHILDREN ARE PRONE TO HIGH REVISION AND COMPLICATION RATES, AND IN THIS STUDY, MISPLACEMENT OF HARDWARE AND PROXIMAL OCCLUSION WERE THE MOST COMMON. COMPLICATION RATES SHOULD NOT BE LIMITED TO REVISION RATES ONLY, AS 30-DAY COMPLICATION RATES INDICATE A SIGNIFICANT RATE OF OTHER COMPLICATIONS AS WELL. MULTI-TARGETED APPROACHES, PERHAPS FOCUSING ON MEASURES TO REDUCE MISPLACEMENT, MAY BE KEY TO REDUCING REVISION RATES. REPORTED EVENTS: 1 PATIENT DEATH PATIENT WITH GLIOBLASTOMA WHO CLINICALLY DETERIORATED WITH ACUTE HYDROCEPHALUS AND RESPIRATORY ARREST, WITH A GCS OF 3 AND DILATED PUPILS, THE PATIENT SUBSEQUENTLY RECEIVED AN EMERGENCY SHUNT BUT DIED WITHIN 2 DAYS DUE TO HERNIATION SECONDARY TO ACUTE HC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921564 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG COVIDIEN LLC UNKNOWN-S

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Male Death