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 Fever (1858); Incontinence (1928); Nausea (1970); Pain (1994); Obstruction/Occlusion (2422)

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 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.

• 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: 8548984
• MDR Text Key: 145648824
• Report Number: 3002647932-2019-00001
• 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: Other
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• 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
• Date Manufacturer Received: 03/28/2019
• 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: 10 YR