MAUDE Adverse Event Report: Q-MED DEFLUX; AGENT, BULKING, INJECTABLE FOR GASTRIUROLOGIC(LMH)

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

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Case reference number (b)(4) is a literature report identified on 15-feb-2022 during literature search.Husaric e, halilbasic a, hotic n.Late presentation of ureterovesical junction obstruction after submucosal transurethral injection of dextranomer/hyaluronic acid copolymer for vesicoureteral reflux.Cent-european-j-paediatr 2021;17(2):110-113.Abstract: objective - we report a case of late-presenting symptomatic ureterovesical junction obstruction after endoscopic treatment of low grade vesicoureteral reflux.Case report - a two-year old girl, with no other underlying conditions, underwent endoscopic submucosal transurethral injection of one ml dextranomer/hyaluronic acid copolymer for grade three vur on the right side.She recovered uneventfully and remained asymptomatic for one year, when she presented with right-side flank pain.Renal ultrasound showed hydronephrosis with calyceal dilatation and hydroureter.Ureterovesical junction obstruction caused by the bulking agent was suspected on mr urography.A large 2×2 cm mass was found extravesically, clearly obstructing the ureter.After excision of the mass and reimplantation of the ureter, the hydronephrosis settled.Conclusion - however rare it is, ureterovesical obstruction may develop after endoscopic submucosal transurethral injection of dextranomer/hyaluronic acid copolymer.Long-term postoperative follow up may be necessary.Case report in december 201:4, a (b)(6) girl presented with urinary tract infection, and was diagnosed with grade three vur of the right-side.She underwent endoscopic treatment, where one ml deflux gel was injected, at another institution.She recovered uneventfully and remained asymptomatic, and no hydronephrosis or vur was demonstrated on her follow up on us and mcug.After one year she presented with right-side flank pain.Renal us showed dilatation of the collecting system of the right kidney, as well as of the right ureter.Repeat mcug did not show vur.Tc-dmsa showed the function of the right kidney at 13%.Obstruction of the right uvj caused by the bulking agent was suspected on the mr urography.Extravesical ureteral reimplantation was planned.A 2×2 cm large mass was found filling the ureter outside the bladder causing clear ureteral obstruction.Postoperative recovery was uneventful.Follow-up us after six months showed significant reduction of the uretero-hydronephrosis.Discussion: in our case, flank pain triggered an investigation one year after the injection.The symptoms and the severe progressive hydronephrosis with hydroureter, the lack of reflux on mcug, and the fall in function on dmsa made the presence of an obstruction obvious, and no mag3 scan was performed.Mru showed a mass at the uvj responsible for the obstruction.Grade v reflux, the presence of a beak sign on the preoperative mcug, and inflamed bladder mucosa upon injection are significant independent risk factors leading to an obstruction.The type of bulking agent used and the injection volume tends to be associated with ureteral obstruction.Vandersteen et al.Suggested that underlying conditions such as neuropathic bladder, dysfunctional voiding, an excess amount of bulking agent injected are also among the risks factors identified for postoperative uvjo.In our case, none of these underlying conditions were identified, however 1ml bulking agent was used to treat a relatively low grade vur, where usually with 0.3 - 0.4 ml, an adequate antireflux effect can be achieved.This may have contributed to the obstruction.However, the fact that the obstruction did not develop rapidly during the postoperative period suggests that other factors, such as late presenting calcification, migration of the bulking agent along the ureter or inflammatory granulation may have also played a role.The 2×2 cm bulk found during the operation could not have come from 1ml deflux alone.Most cases of early ureteral obstruction reported in the literature were treated successfully with temporary double-j stenting, however late-presenting cases required open ureteral reimplantation.In our case the large mass causing the obstruction was removed and the reimplantation was successful.Conclusion: an increasing number of early and delayed ureteral obstructions are being reported following the sting procedure, although the incidence is still lower than the rate associated with open surgery.Since delayed ureteral obstruction, resulting in silent loss of renal function, may occur as long as 4 or 5 years after the injection, long-term follow up seems to be reasonable.

Manufacturer Narrative

Company comment: the serious events of congenital megaureter, implant site mass, hydronephrosis, hydroureter and the non-serious event of flank pain were considered expected and possibly related to the treatment.Serious criteria include the need for surgical intervention to prevent permanent damage.Potential root cause include treatment procedure.The case meets the criteria for expedited reporting to the regulatory authorities.Product notes: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported and the product could not be verified.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.

• Brand Name: DEFLUX
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRIUROLOGIC(LMH)
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 13773291
• MDR Text Key: 292388513
• Report Number: 9710154-2022-00015
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: BK
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/15/2022
• 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: 24 MO
• Patient Sex: Female