BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFLUX INJECTABLE GEL

    MDR report key: 2468915 · Received February 22, 2012

    Report

    Report Number
    3007923369-2012-00002
    Event Type
    Injury
    Date Received
    February 22, 2012
    Report Date
    January 27, 2012
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P000029
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZEMPLE RP, ET AL., DELAYED ONSET URETERAL OBSTRUCTION FOLLOWING DEFLUX INJECTION FOR VESICOURETERAL REFLUX. J OF PEDIATRIC UROLOGY (2012), DOI:10.1016/J. JPUROL.2011.12.007. URETERAL OBSTRUCTION IS A KNOWN AND LABELED ADVERSE EVENT ASSOCIATED WITH SUBURETERAL INJECTION PROCEDURES. TIME TO ONSET IS LATER THAN EXPECTED. THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVALUATION. DEVICE FAILURE/OUT OF SPECIFICATION CONDITION IS NOT SUSPECTED.

    Description of Event or Problem · 1

    THE ATTACHED ARTICLE WAS REPORTED IN THE PUBLISHED LITERATURE AND DESCRIBES A NOVEL APPROACH WHICH INVOLVES EXCISION OF THE INJECTED AREA TO REMOVE THE DEXTRANOMER/HYALURONIC ACID COPOLYMER (DEFLUX) IMPLANTATION. THE PT WAS DIAGNOSED WITH BILATERAL REFLUX AS AN INFANT DURING A WORK-UP OF PRENATAL HYDRONEPHROSIS. POSTNATALLY, HIS BILATERAL HYDRONEPHROSIS IMPROVED ON SEQUENTIAL ULTRASOUNDS AND WAS RESOLVED BY (B)(6). VOIDING CYSTOURETHROGRAM (VCUG) EVALUATION SHOWED GRADE 2 RIGHT AND GRADE 4 LEFT VUR, SUBSEQUENT VCUG DEMONSTRATED GRADE 3 ON THE RIGHT AND GRADE 1 ON THE LEFT. A DIURETIC RENOGRAM WAS OBTAINED TO EVALUATE FUNCTION AS RENAL ASYMMETRY WAS NOTED ON ULTRASOUND. IT SHOWED 66% FUNCTION ON RIGHT AND 34% ON LEFT KIDNEY. THE WASHOUT OF THE BILATERAL COLLECTING SYSTEMS WAS NOT CONSISTENT WITH OBSTRUCTION. AT (B)(6), THE PT UNDERWENT ENDOSCOPIC INJECTION OF 1.0 ML OF DEFLUX INTO EACH URETER USING THE STING TECHNIQUE. A 3-MONTH FOLLOW UP SHOWED NEITHER HYDRONEPHROSIS NOR VUR. NO EVIDENCE OF OBSTRUCTION OR ANY URINARY TRACT INFECTIONS DURING THE POST-INJECTION PERIOD. AT 18 MONTHS ULTRASOUND DEMONSTRATED HYDROURETERONEPHROSIS ON THE LEFT SIDE. FOLLOW UP DIURETIC RENOGRAPHY SHOWED STABLE FUNCTION FROM PREOPERATIVE STUDIES AND NO HIGH-GRADE OBSTRUCTION. THE HYDRONEPHROSIS WORSENED SLOWLY OVER 4 YEARS. AT 3 YEARS POST INJECTION THERE WAS STILL NO OBSTRUCTION OF RENOGRAM, BUT AT (B)(6) THE EXCRETORY CURVE HAD WORSENED AND DIURETIC T 1/2 HAD INCREASED FROM 0.5 TO 14.6 S. THE ADVERSE EVENT OCCURRED 18 MONTHS AND 4 YEARS AFTER TREATMENT AND ARE: HYDROURETERONEPHROSIS [HYDRONEPHROSIS] AT 18 MONTHS AFTER TREATMENT AND PARTIAL URETERIC OBSTRUCTION [URETERIC OBSTRUCTION] AT 4 YEARS AFTER TREATMENT. THE DECISION TO EXCISE THE DEFLUX WAS MADE TO AMELIORATE THE RISKS ASSOCIATED WITH PARTIAL OBSTRUCTION. PEDIATRIC CYSTOSCOPE WAS USED TO VISUALIZE BILATERAL DEFLUX MOUNDS UNDER THE URETERAL ORIFICES. A DOUBLE-J URETERAL STENT WAS PLACED TO ENSURE GOOD VISUALIZATION OF THE ORIFICE. A SMALL PUNCTURE WAS MADE AT THE VERY MEDIAL, DISTAL ASPECT OF THE DEFLUX MOUND USING A 2-FR BUGBEE. EVENTUALLY THIS PUNCTURE SITE WAS EXTENDED, KEEPING AS MUCH DISTANCE AS POSSIBLE FROM THE URETERAL ORIFICE. THE DEFLUX MATERIAL WAS IRRIGATED WITH SALINE AND THE TIP OF THE CYSTOSCOPE WAS USED TO PERFORM GENTLE, MECHANICAL AGITATION. COMPLETE EVACUATION OF THE CAVITY WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFLUX INJECTABLE GEL AGENT, BULKING, INJECTABLE LNM Q-MED AB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention