MAUDE Adverse Event Report: UROPLASTY, LLC MACROPLASTIQUE IMPLANTS; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Model Number MPQ-2.5

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Calcium Deposits/Calcification (1758); Pain (1994); Hematuria (2558); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• Manufacturer (Section G): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• Manufacturer Contact: nicole boser ; 5420 feltl road; minnetonka, MN 55343 ; 9524266141
• MDR Report Key: 8548960
• MDR Text Key: 145648746
• Report Number: 3002647932-2019-00002
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P040050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MPQ-2.5
• Device Catalogue Number: MPQ-2.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR