MAUDE Adverse Event Report: VALEANT PHARMACEUTICALS, INC DEFLUX INJECTABLE GEL; AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE

Model Number DEFLUX

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

A published article titled "a rare complication of deflux endoscopic management of vesicoureteral reflux in children" reports two cases of secondary megaureter after deflux injections.This report references case 2 of 2.The patient had an ultrasound performed at birth because of pretragal cyst.The ultrasound revealed right pyelo-calyceal dilation (17 mm).The cystography concluded to a bilateral vesicorenal reflux of high grade.Ultrasound performed afterward found the bilateral pyelo-calyceal dilation but also a dilation of the right retrovesical ureter.Few weeks before deflux injection, ultrasound performed found the right retrovesical ureter at 5 mm and 3mm for the left one.Due to iterative pyelonephritis (5 in total) despite an antibioprophylaxis, it was decided to perform bilateral deflux injection (one injection per ureter) at the age of (b)(6).One month after the injection, the dilation of the distal ureters doubled, more important for the right ureter with a diameter of 10 mm and 3.7mm for the left one.Because of other episodes of pyelonephritis despite an antibioprophylaxis, it was decided to perform a bilateral surgery with cohen procedure at the age of (b)(6).Per-operatively because the distal ureter was dilated it was resected.There was no problem postoperatively.

Manufacturer Narrative

The product was not returned to b+l for evaluation and the lot number was not provided; therefore a dhr review could not be performed.Based on the current information the root cause of the event could not be conclusively determined.

• Brand Name: DEFLUX INJECTABLE GEL
• Type of Device: AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): VALEANT PHARMACEUTICALS, INC; rochester NY 14609
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala 75228 ; SW 75228
• Manufacturer Contact: faranak gomarooni ; 50 technology drive west; irvine, CA 92618 ; 9493985708
• MDR Report Key: 6397789
• MDR Text Key: 69734628
• Report Number: 3009443653-2017-00009
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: DEFLUX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/11/2017
• Supplement Dates Manufacturer Received: 02/10/2017
• Supplement Dates FDA Received: 12/15/2017
• 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): Other
• Patient Age: 2 YR