BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HAKIM VALVE

    MDR report key: 8005679 · Received October 25, 2018

    Report

    Report Number
    1226348-2018-10747
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    August 1, 2017
    Report Date
    October 2, 2018
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI -- UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿SPACE-OCCUPYING TUMOR BED CYSTS AS A COMPLICATION OF MODERN TREATMENT FOR HIGH- GRADE GLIOMA¿ BY THOMAS BEEZ, SVEN BURGULA, MARCEL KAMP, MARION RAPP, HANS-JAKOB STEIGER, AND MICHAEL SABEL, PUBLISHED WORLD NEUROSURG. (2017) 104:509-515. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2017.05.019, IT WAS REPORTED THAT AFTER IMPLANT OF UNKNOWN CHPV DEVICES, 4 PATIENTS HAD INFECTIONS WITH DEVICE REVISION. PER THE ARTICLE: ¿THE MANAGEMENT OF HIGH-GRADE GLIOMA (HGG) HAS BEEN AFFECTED BY RECENT LANDMARK TRIALS AND IS NOW MORE PROACTIVE. MORE AGGRESSIVE TREATMENT LEADS TO HOSPITALIZATION DUE TO SIDE EFFECTS; HOWEVER, SPACE OCCUPYING TUMOR BED CYSTS HAVE BEEN DESCRIBED, BUT NOT SYSTEMATICALLY ASSESSED. WE SOUGHT TO ANALYZE THIS COMPLICATION IN A CONTEMPORARY HGG COHORT¿. SEVEN PATIENTS WERE TREATED WITH A CYSTOPERITONEAL SHUNT, AND 5 PATIENTS WERE TREATED WITH A VENTRICULOPERITONEAL SHUNT. IN ALL CASES, AN ADJUSTABLE DIFFERENTIAL PRESSURE VALVE WAS IMPLANTED (CODMAN HAKIM VALVE). ALTHOUGH 9 PATIENTS HAD A CLINICAL BENEFIT FROM THIS INTERVENTION, WITH COMPLETE REMISSION OF THE NEW SYMPTOMS ATTRIBUTED TO THE TUMOR BED CYST, IN 3 PATIENTS CLINICAL STATUS REMAINED UNCHANGED DESPITE RADIOLOGIC IMPROVEMENT OF THE SPACE-OCCUPYING EFFECT. THE MEDIAN OVERALL SURVIVAL WAS 6.5 MONTHS (RANGE, 1E125 MONTHS) AFTER TREATMENT OF THE TUMOR BED CYST. REGARDING SHUNT COMPLICATIONS, 9 REVISIONS WERE PERFORMED IN 4 PATIENTS. THERE WERE 4 EPISODES OF SHUNT INFECTION, 3 REVISIONS FOR MISPLACED PROXIMAL CATHETERS, AND 2 REVISIONS DUE TO PROXIMAL OCCLUSION OF THE SHUNT.¿ NO FURTHER DETAIL WAS PROVIDED REGARDING THE TREATMENT OF THE INFECTION, NOR OF THE TYPE OF ORGANISM CAUSING THE INFECTION. AT THE TIME OF COMPLAINT ENTRY, NO PATIENT OR DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845927 UNKNOWN HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other