BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK EVD

    MDR report key: 7168411 · Received January 5, 2018

    Report

    Report Number
    1226348-2018-10021
    Event Type
    Injury
    Date Received
    January 5, 2018
    Date of Event
    July 24, 2017
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE. IT IS NOT CLEAR AT THIS POINT IF THE DEVICE AND/OR LOT INFORMATION IS AVAILABLE. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF THE DEVICE IS RETURNED THE COMPLAINT WILL BE INVESTIGATED AND A FOLLOW UP REPORT WILL BE FILED. IF LOT INFORMATION DOES BECOMES AVAILABLE AND IF THE RECORD REVIEW INDICATES THAT THERE WAS A NON-CONFORMITY A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE CONVERSION OF EXTERNAL VENTRICULAR DRAINAGE TO VENTRICULO-PERITONEAL SHUNT: TO CHANGE OR NOT TO CHANGE THE PROXIMAL CATHETER? PUBLISHED CHILDS NERV SYST (2017) 33:1947¿1952DOI 10.1007/S00381-017-3544- IT WAS REPORTED THAT PATIENT #4, A (B)(6) FEMALE PRESENTED WITH METASTATIC PA (PILOCYTIC ASTROCYTOMA) WITH THE INDICATION FOR SHUNT BEING A TRAPPED 4TH VENTRICLE. APPROXIMATELY 9 DAYS POST INSERTION, THERE WAS A REPORTED PRODUCT MALFUNCTION. PER THE ARTICLE ¿PURPOSE: IN THIS STUDY, WE INVESTIGATE THE OCCURRENCE RATE OF EARLY SHUNT INFECTION AND MALFUNCTION IN PEDIATRIC PATIENTS AFTER CONVERTING AN EXTERNAL VENTRICULAR DRAINAGE (EVD) TO A VENTRICULO-PERITONEAL SHUNT (VPS) WITHOUT REPLACING THE VENTRICULAR CATHETER. METHODS DATA WAS RETROSPECTIVELY REVIEWED FOR 17 PEDIATRIC PATIENTS (11 MALE (64.7%), MEAN AGE 7.5 YEARS, RANGE 0.25¿ 15 YEARS) WHO UNDERWENT 18 CONSECUTIVE DIRECT CONVERSIONS OF TUNNELED EVD TO VPS WITHOUT REPLACING THE VENTRICULAR CATHETER BETWEEN 2008 AND 2017. IN EACH CASE, THE EVD WAS INSERTED IN STERILE FASHION WITHIN THE OPERATING ROOM AND TUNNELED SUBCUTANEOUSLY 5¿7 CM AWAY FROM THE INSERTION SITE. PRIMARY OUTCOME MEASURE WAS THE OCCURRENCE OF EARLY (WITHIN 30 DAYS) VPS INFECTION OR MALFUNCTION. THE MEAN FOLLOW-UP TIME WAS 56.8 MONTHS (±35.7 MONTHS) ¿. CONCLUSION IN THE PEDIATRIC POPULATION, THE CONVERSION OF A TUNNELED EVD TO A VPS WITHOUT REPLACING THE VENTRICULAR CATHETER CAN BE SAFELY DONE.¿ ALSO PER THE ARTICLE: ¿EARLY SHUNT MALFUNCTION OCCURRED AFTER 9 DAYS IN ONE PATIENT (5.6%). THIS PATIENT SUFFERED FROM A METASTATIC PILOCYTIC ASTROCYTOMA (PA) WITHIN THE THIRD VENTRICLE AND UNDERWENT REPEATED SUPRATENTORIAL TUMOR SURGERIES AND INSERTION OF AN OCCIPITAL VPS. LATER, DUE TO TUMOR PROGRESSION, A TRAPPED 4TH VENTRICLE BECAME EVIDENT. THIS WAS ADDRESSED BY AN INFRATENTORIAL CRANIOTOMY, RESECTION OF THE TONSILS, OPENING OF ARACHNOIDAL WEBS TOWARD THE SPINAL SUBARACHNOID SPACE, AND INSERTION OF A LUMBOPERITONEAL TUBE FROM THE 4TH VENTRICLE TOWARD THE SPINAL SUBARACHNOID SPACE, ACTING AS A LOCAL STENT. SINCE NO CLINICAL AND RADIOLOGICAL IMPROVEMENT WAS OBSERVED POST-OPERATIVELY, THE PATIENT WAS TAKEN TO SURGERY AGAIN 3 DAYS LATER, WHERE AN OPEN REDO SURGERY WAS DONE AND AN EVD LEFT IN THE 4TH VENTRICLE. THE PATIENT IMPROVED, BECOMING SHUNT DEPENDENT, AND THEREFORE THE EVD WAS CONVERTED INTO A VPS AFTER 11 DAYS. NINE DAYS LATER, A NEUROLOGICAL DECLINE WAS SEEN, WHILE ON IMAGING A RECURRENCE OF THE TRAPPED 4TH VENTRICLE WAS APPARENT. THE PATIENT WAS TAKEN TO SURGERY, WHERE A DISLOCATION OF THE VENTRICULAR CATHETER FROM WITHIN THE 4TH VENTRICLE WAS SEEN. 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
    13082 UNK EVD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention