BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEUROPEN

    MDR report key: 7239854 · Received February 3, 2018

    Report

    Report Number
    2021898-2018-00057
    Event Type
    Injury
    Date Received
    February 3, 2018
    Date of Event
    December 16, 2017
    Report Date
    February 3, 2018
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWG
    PMA / PMN Number
    K003914
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: A STERILE 15-CM SEMI-RIGID (1.14 MM IN DIAMETER) STYLET NE UROENDOSCOPE (NEUROPEN) IS INSERTED INTO A VENTRICULAR SLOTTED INNERVISION CATHETER (2.8 MM IN OUTER DIAMETER) WITH A DISTAL SLIT TIP (INNERVISION VENTRICULAR CATHETER). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    WENJUN SHEN, HASAN R. SYED, GURPREET GANDHOKE, ROXANNA GARCIA, TATIANA PUNDY, TADANORI TOMITA. ENDOSCOPIC THIRD VENTRICULOSTOMY IN CHILDREN WITH A FIBER OPTIC NEUROENDOSCOPY. CHILD'S NERVOUS SYSTEM. DOI: 10.1007/S00381-017-3679-4. ABSTRACT: OBJECTIVE: ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) PROVIDES A SHUNT-FREE TREATMENT FOR OBSTRUCTIVE HYDROCEPHALUS CHILDREN. WITH RAPIDLY EVOLVING TECHNOLOGY, THE SEMI-RIGID FIBER OPTIC NEUROENDOSCOPY SHOWS A POTENTIAL APPLICATION IN ETV BY BLUNT FENESTRATION. A RETROSPECTIVE ANALYSIS OF OUR EXPERIENCE IS REVIEWED. METHODS: THE AUTHORS REVIEW INFANTS AND CHILDREN WHO UNDERWENT ETV USING THIS TECHNIQUE FROM JUNE 2004 TO JUNE 2016 WITH RADIOLOGICAL AND CLINICAL FOLLOW-UP DONE BY A SINGLE SURGEON. PATIENTS WHO UNDERWENT ETV WITH CHANNEL SCOPE WERE EXCLUDED. DEMOGRAPHIC VARIABLES AND OPERATIVE REPORTS WERE COLLECTED. IMPROVEMENT OF PREOPERATIVE SYMPTOMS AND AVOIDANCE OF ADDITIONAL CEREBROSPINAL FLUID (CSF) DIVERSION PROCEDURES WERE CONSIDERED A SUCCESS. THE ETV SUCCESS SCORE (ETVSS) WAS USED TO CORRELATE WITH CLINICAL OUTCOMES. RESULTS: A TOTAL OF 79 PATIENTS WERE INCLUDED WITH A MEAN AGE OF 8.3 ± 5.5 YEARS, AND 40.5% WERE FEMALE. THE MEAN CLINICAL AND RADIOGRAPHIC FOLLOW-UP WAS 38.6 ± 40.9 MONTHS. THE OVERALL COMPLICATION RATE WAS 6.3%, WHILE 73.4% WERE CONSIDERED SUCCESSFUL. THE ETV FAILURE CASES RECEIVED CONVERSION TO VENTRICULOPERITONEAL SHUNT OR REDO OF ETV WITH A MEDIAN TIME OF 2 MONTHS. THE MEAN ETV SUCCESS SCORE WAS 74.3 ± 11.8 WITH POSITIVE CORRELATION BETWEEN SUCCESS RATE (P <(><<)> 0.05). KAPLAN-MEIER FAILURE-FREE SURVIVAL RATES OF 30-DAY, 90-DAY, 6-MONTH, 1-YEAR, AND 2-YEAR WERE 89.9, 83.5, 78.5, 75.9, AND 74.6%. EIGHT PATIENTS REQUIRED REDO ETV, AND FIVE OF THESE PATIENTS REQUIRED EVENTUAL SHUNT PLACEMENTS. APPROXIMATELY 61.9% OF FAILURE OCCURRED WITHIN 3 MONTHS. PATIENTS WITH POST-INTRAVENTRICULAR HEMORRHAGE (IVH) /INFECTION, AND AGE YOUNGER THAN 12 MONTHS HAD THE POOREST OUTCOME (P <(><<)> 0.05). CONCLUSIONS: BLUNT DISSECTION OF THE THIRD VENTRICLE FLOOR UNDER ENDOSCOPIC VISION WITH THE STYLET TIP OF A FIBER OPTIC NEUROENDOSCOPY IS SAFE AND REQUIRES LESS EQUIPMENT IN THE PEDIATRIC POPULATION. THIS TECHNIQUE IS SUCCESSFUL WITH AN OPTIMISTIC LONG-TERM OUTCOME EXCEPT FOR INFANTS AND THE POST-IVH AND INFECTIOUS SUBGROUPS. REPORTED EVENTS: 8 PATIENTS REQUIRED REDO ETV; 3 REDOS IN 1 CHILD AND A SINGLE REDO IN 7 CHILDREN. ONE PATIENT EXPERIENCED INTRAOPERATIVE VENOUS HEMORRHAGES, WHICH REQUIRED TEMPORARY EXTERNAL VENTRICULAR DRAINAGE (EVD). TWO PATIENTS EXPERIENCED MINOR INTRAOPERATIVE HEMORRHAGES WITHOUT EVD. 3 PATIENTS EXPERIENCED POST-OPERATIVE STAPH VENTRICULITIS. 5 OUT OF 6 PATIENTS WHO EXPERIENCED COMPLICATIONS REQUIRED THE PLACEMENT OF A VENTRICULOPERITONEAL SHUNT EVENTUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83340 UNKNOWN NEUROPEN ENDOSCOPE, NEUROLOGICAL GWG MEDTRONIC NEUROSURGERY UNKNOWN-ES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| R