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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Granuloma (1876)

Event Type  malfunction  

Manufacturer Narrative

Macroplastique implants are not indicated for treatment of vur within the united states (only female sui), however the vur inidication exists for all geographies outside 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 mpq was reqmoved 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.Additionally, this report is being submitted to fda more than 30 days after the initial awareness date as the literature was published in (b)(4) and translations of the article were necessary in order to evalute whether or not the event described was reportable.

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) year old man received mpq treatment for vur 7 years previous.Micturating cystourethrography had shown that the vur had disappeared.The patient presented with left abdominal pain as a main complaint.No hydronephrosis was shown in computer tomography however an approximately 8.3 mm sized stone was shown in the left vesicoureteral junction near where the mpq had been previously injected.Ureteral endoscopy showed a protuberant granulation tissue inside the bladder directly below the left ureteral orifice which was firmly attached to the stone.The stones were removed via holmium: yag laser, crushed and then removed from the patient's body.

• 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: 8595744
• MDR Text Key: 144824333
• Report Number: 3002647932-2019-00003
• 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: 05/08/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 05/09/2019
• 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: 39 YR