BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACROPLASTIQUE IMPLANTS

    MDR report key: 8548984 · Received April 25, 2019

    Report

    Report Number
    3002647932-2019-00001
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Report Date
    April 19, 2019
    Manufacturer
    UROPLASTY, LLC
    Product Code
    LNM
    PMA / PMN Number
    P040050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MACROPLASTIQUE IMPLANTS ARE NOT INDICATED FOR TREATMENT OF VUR WITHIN THE UNITED STATES (ONLY FEMALE SUI), HOWEVER THE VUR INDICATION EXISTS FOR ALL GEOGRAPHIES OUTSIDE OF THE US. THIS EVENT IS BEING CONSERVATIVELY REPORTED TO FDA AS A) IT WAS UNCLEAR BASED ON THE CONTENT OF THE PUBLISHED CASE STUDY WHETHER OR NOT THE MACROPLASTIQUE WAS REMOVED AT THE TIME OF BLADDER STONE REMOVAL AND B) DUE TO THE FACT THAT TREATMENT WITH MPQ FOR VUR IS SIMILAR TO THAT FOR SUI AND THEREFORE THIS TYPE OF EVENT HAS THE POTENTIAL TO OCCUR WITHIN THE US.

    Description of Event or Problem · 1

    THIS EVENT WAS DISCOVERED DURING A LITERATURE SEARCH RELATED TO MACROPLASTIQUE FOR VESICOURETERAL REFLUX (VUR) AND IS IN THE FORM OF A CASE STUDY. A (B)(6) FEMALE PATIENT HAD UNDERGONE SUBURETERAL ADMINISTRATION OF MPQ TO TREAT BILATERAL VUR WHEN SHE WAS (B)(6). THE PATIENT PRESENTED WITH RIGHT FLANK PAIN, NAUSEA AND FEVER AND HAD RECURRENT LOWER URINARY TRACT SYMPTOMS, INCLUDING DYSURIA, FREQUENCY AND URGENCY FOR 6 MONTHS PREVIOUS, WHICH WERE PARTIALLY RELIEVED FROM EMPIRICAL ANTIBIOTICS FOR 3 DAYS. ULTRASONOGRAPHY REVEALED A MODERATE DEGREE HYDRONEPHROSIS ON THE RIGHT KIDNEY AND TWO BLADDER STONES (2.0 CM AND 1.3 CM) NEAR THE RIGHT TRIGONAL AREA OF THE BLADDER. A FOLLOW UP URINALYSIS WAS PERFORMED WHICH SHOWED THAT THE PATIENT'S SYMPTOMS AND PYURIA HAD RESOLVED IN SEVEN DAYS. THE PATIENT WAS DIAGNOSED WITH DISTAL URETERAL OBSTRUCTION INDUCED BY BLADDER SONE AND A CYSTOLITHOLAPAXY AND RIGHT RETROGRADE PYELOGRAPHY (RGP) WERE PERFORMED. CYSTOSCOPY SHOWED TWO YELLOWISH IMPACTED STONES ATTACHED TO THE PREVIOUS SITE OF MPQ ADMINISTRATION, JUST BELOW THE RIGHT URETERAL ORIFICE. THE STONES WERE COMPLETELY REMOVED USING CYSTOLITHOLAPAXY, HOWEVER IT IS UNCLEAR WHETHER OR NOT THE MACROPLASTIQUE WAS ALSO REMOVED AT THIS TIME. RGP WAS PERFORMED TO EVALUATE OTHER POTENTIAL CAUSES OF URETERAL OBSTRUCTION AND SHOWED THAT THE HYDRONEPHROSIS WAS CAUSED BY THE PRESENCE OF BLADDER STONES AND NOT VUR. THE PATIENT WAS MONITORED EVERY THREE MONTHS FOR A 12 MONTH POST-OPERATIVE PERIOD AND HAD NO ABNORMAL FINDING OR LOWER URINARY TRACT SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343941 MACROPLASTIQUE IMPLANTS AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM UROPLASTY, LLC MPQ-2.5

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention