BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACROPLASTIQUE IMPLANTS

    MDR report key: 8548960 · Received April 25, 2019

    Report

    Report Number
    3002647932-2019-00002
    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
    PHYSICIAN

    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 (MPQ) FOR TREATMENT OF VESICOURETERAL REFLUX (VUR) AND WAS FOUND IN THE FORM OF A CASE STUDY. A (B)(6) MALE PATIENT HAD UNDERGONE TREATMENT WITH MPQ WHEN HE WAS 9 MONTHS OF AGE AFTER BEING DIAGNOSED WITH UNILATERAL GRADE V VUR. THE PATIENT PRESENTED WITH INTERMITTENT GROSS HEMATURIA AND SUPRA-PUBIC PAIN FOR SEVERAL MONTHS. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR SUSPECTED CYSTITIS AND THE SYMPTOMS DISAPPEARED WITHIN SEVERAL DAYS. TWO YEARS AFTER THE MPQ INJECTION, THE PATIENT PRESENTED WITH GROSS HEMATURIA (FOUR TIMES) AND MICROSCOPIC HEMATURIA (TWO TIMES). WHENEVER HEMATURIA WAS PRESENT, THE PATIENT'S URINE CALCIUM/CREATININE RATIO WAS CHECKED AND RESULTS WERE NORMAL. URINALYSIS SHOWED ISOMORPHIC HEMATURIA AND MILD PROTEINURIA. A CT SCAN WAS PERFORMED AND SHOWED TWO 0.7 CM HYPERDENSE LESIONS IN THE LEFT POSTERIOR ASPECTS OF THE BLADDER AND SUSPECTED STONES AT THE UVJ OR IN THE BLADDER. ULTRASONOGRAPHY SHOWED PREVIOUS MILD PELVIRECTAL OF THE LEFT KIDNEY (0.3 CM) AND TWO HYPERECHOIC FOCI WITH POSTERIOR ACOUSTIC SHADOWING IN THE LEFT POSTERIOR ASPECT OF THE BLADDER. A DIAGNOSTIC CYSTOSCOPY WAS PERFORMED SHOWING CALCIFICATIONS LEADING TO MUCOSAL EROSIONS AROUND THE ORIFICE WHERE MPQ HAD BEEN PREVIOUSLY INJECTED. THE CALCIFICATIONS ON THE MUCOSAL AREA WERE SUCCESSFULLY REMOVED VIA LASER, HOWEVER IT IS UNCLEAR IF ANY MPQ WAS ALSO REMOVED AT THIS TIME. THE PATIENT'S SYMPTOMS WERE GRADUALLY RELIVED AFTER TREATMENT AND ROUTINE MONITORING FOR SEVEN MONTHS AFTER THE REMOVAL OF THE CALCIFICATIONS SHOWED NO RECURRENT SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343924 MACROPLASTIQUE IMPLANTS AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM UROPLASTY, LLC MPQ-2.5

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention