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

Model Number DEFLUX

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Renal Failure (2041); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Literature article "delayed obstruction with asymptomatic loss of renal function after dextranomer/hyaluronic acid copolymer (deflux) injection for vesicoureteral reflux: a close look at a disturbing outcome" by dimitri papagiannopoulos, ilina rosoklija, earl cheng, elizabeth yerkes, reports: "three cases where deflux was used in off-label fashion, resulting in delayed ureteral obstruction and loss of renal function (range 18-52 months post-operatively).We now place increased emphasis on the need for long-term follow-up after deflux in both routine and complex cases, particularly in situations of off-label use." case one of three: a (b)(6) patient with neurogenic bladder, a notable decline in renal function and renal parenchymal loss on the left kidney (vcug grade: 3, pelviectasis and dmsa: 27%df) was treated with double hit deflux injection.During intraoperative observations the surgeon noticed distally ectopic but intravesical ureter.Patient developed febrile uti and chronic urothelial inflammation after 18 months.Ultra sonography showed left kidney grade 4 hun, and dmsa: 16% df.Patient was treated with open ureteral re-implantation with extravesical dissection.

Manufacturer Narrative

During an internal review, it was identified that the medwatch report for this event was electronically submitted to fda with an mdr number that was generated using (b)(4) as the registration number.The correct registration number that should have been used to generate the mdr number is (b)(4).

Manufacturer Narrative

The device is not available to return 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): SALIX PHARMACEUTICALS, INC.; raleigh NC
• 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: 6067922
• MDR Text Key: 58795967
• Report Number: 0001313525-2016-00500
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• 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
• Date Manufacturer Received: 10/04/2016
• 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: 3 YR