MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUFILL N-BCA-1 GRAM KIT; TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS

Model Number	631-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	02/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Bamezai s, aronberg rm, park jm, gemmete jj.Intranodal lymphangiography and interstitial lymphatic embolization to treat chyluria caused by a lymphatic malformation in a pediatric patient.Pediatr radiol.2021 aug;51(9):1762-1765.Doi: 10.1007/s00247-021-05007-w.Epub 2021 feb 27.Pmid: 33638694.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.Since the product has not been returned, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The trufillln-bca liquid embolic system is indicated for the embolization of cerebral arteriovenous malformations (avms) when pre-surgical devascularization is desired.Per the publication, glue migration into the urinary collecting system is a potential complication of this procedure that can be mitigated by adjusting the n-bca dilution with lipiodol.Review of the available information suggests that patient and procedural factors including the off-label use of the trufill n-bca in the setting of interstitial lymphatic embolization may have contributed to the reported event.There is no indication that the trufill n-bca product malfunctioned or that it is related to the product design or manufacturing process.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
This complaint is from a literature source.The literature citation is as follows: bamezai s, aronberg rm, park jm, gemmete jj.Intranodal lymphangiography and interstitial lymphatic embolization to treat chyluria caused by a lymphatic malformation in a pediatric patient.Pediatr radiol.2021 aug;51(9):1762-1765.Doi: 10.1007/s00247-021-05007-w.Epub 2021 feb 27.Pmid: 33638694.Objective and methods: the purpose of the article was to present a pediatric case of persistent chyluria from a lymphatic malformation which required intranodal lymphangiography and interstitial lymphatic embolization.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: trufill n-butyl cyanoacrylate (n-bca) embolic agent.Other cerenovus devices that were also used in this study: n/a.Non-cerenovus devices that were also used in this study: n/a.Adverse event(s) and provided interventions: a (b)(6) year-old boy presented to the emergency department with onset of gross hematuria and a 3- month history of chyluria.Cystoscopy demonstrated milky urine entering the bladder through the left ureteral orifice.Intranodal dynamic contrast-enhanced magnetic resonance (mr) lymphangiography showed a left retroperitoneal lymphatic malformation extending into the renal hilum with associated lymphangiectasia.Intranodal lymphangiography and interstitial lymphatic embolization were performed under general anesthesia to embolize the retroperitoneal lymphatic malformation communicating with the left kidney.1.8 ml of a 1:3 trufill n-bca to lipiodol mixture was injected into the dilated lymphatic channels at the l1-l2 level.Postoperatively, the patient continued to pass milky urine as well as solid particulate, which caused intermittent difficulty urinating.A repeat embolization was performed 4 months after the initial procedure.N-bca diluted 1:4 with lipiodol was injected into the lymphatic channel.The injection of diluted n-bca was repeated at two sites of abnormal connection identified on the lymphangiogram within the mid and upper pole calyx.A total of 8 ml n-bca mixed 1:4 with lipiodol was used.However, the injection was stopped upon opacification of lymphatic channels emptying into the left upper pole collecting system.To prevent acute urinary obstruction, urology placed a retrograde jj stent extending from the renal pelvis into the bladder.Postoperatively, the patient experienced resolution of chyluria and subsequently had the stent removed.Four months post-embolization, the patient presented to the emergency department with passage of yellow clots and severe left flank pain.Renal ultrasound images were consistent with obstructive n-bca at the left ureteropelvic junction.Urology inserted a jj stent in the left ureter.During the stent removal, partially calcified n-bca in the renal collecting system was observed and removed via direct vision ureteroscopy.The patient presented to interventional radiology 3 months later with continued resolution of chyluria and a recurrent, single painless episode of passing glue.

• Brand Name: TRUFILL N-BCA-1 GRAM KIT
• Common Device Name: TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 12604857
• Report Number: 3008114965-2021-00511
• Device Sequence Number: 3473327
• Product Code: KGG
• UDI-Device Identifier: 10886704029151
• UDI-Public: 10886704029151
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P990040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: 631-500
• Device Catalogue Number: 631500
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Weight: 55