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

Catalog Number 631500

Device Problem Chemical Problem (2893)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Respiratory Failure (2484); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2023

Event Type  Injury  

Event Description

The healthcare professional reported that during an endovascular embolization procedure to treat vein of galen malformation (vogm) in a 12-day old patient, the physician used a mixture of trufill¿ n-bca 1-gram kit liquid embolic system (631500/lot# unknown) and tantalum powder without any ethiodized oil.It was reported that the physician was informed that it was contraindicated to use the n-bca without the oil.The physician reported that the n-bca/tantalum mixture never exited the microcatheter (unspecified brand).The physician used dextrose 5% in water (dw5) to rinse the hub and the inner lumen of the microcatheter before injection of the n-bca/tantalum mixture.The procedure was not successfully completed with a less than desirable treatment outcome; no reason was reported at the time of the complaint initiation.There was no report of any negative patient impact; no other medical intervention required.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, gender, weight, race, and ethnicity were not provided.Section d4: the expiration date of the device is not known as the device lot number is not available/not reported.Section h4: the device manufacture date is not known as the device lot number is not available/not reported.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Per the instruction for use (ifu), separate use of the individual components of the trufill n-bca liquid embolic system is contraindicated.The components must be used as a system.With the information available and without the complaint product available to be returned for analysis, the reported issue documented in the complaint cannot be confirmed through functional evaluation and analysis.The lot number of the device is not known; therefore, manufacturing documentation review was not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 05-oct-2023.[additional information]: on 05-oct-2023, additional information was received.Related to the characteristics of the target site, the information indicated that it was ¿close to the fistula point from the anterior choroidal artery, in tortuous artery, with very high flow.¿ there were no discrepancies nor abnormalities noted with any of the components prior to use or during mixing of the trufill n-bca liquid embolic.The microcatheter used was a headway® duo 167 microcatheter (microvention).The additional information indicated that there was further decline in respiration and hemodynamics of the patient, concurrent with the catheter getting glued in and avulsing the artery upon withdrawal.This was the reason it was indicated that the procedure was not successfully completed.Per the information, the less than desirable outcome of the procedure was because, ¿given the patient¿s progressive instability, [the] anesthesia team had to get the patient back to the neonatal intensive care unit (nicu).¿ the event of the trufill n-bca liquid embolic agent being mixed with tantalum, causing a microcatheter to be glued to an artery and avulsing the artery upon withdrawal, was discussed with the medical safety officer (mso) on 06-oct-2023.Per the mso, without the use of ethiodized oil as a polymerization retardant, the n-bca/tantalum mixture is expected to polymerize immediately on exiting the catheter once in contact with blood.This is well known and would thus account for the catheter becoming glued to the vessel wall and the subsequent vessel perforation resulting from attempted catheter removal by retraction pull force.It is likely that the effects of vessel perforation resulted in the series of observed events: respiratory distress, hemodynamic instability, and prolonged critical care hospitalization for the patient.A catheter becoming glued to a vessel and vessel perforation are both known potential complications associated with the use of the trufill n-bca liquid embolic system and are listed in the instructions for use (ifu) as such.The ¿inadequate polymerization-polymerized too fast¿ of the trufill n-bca occurred because the system was not used according to the ifu.As stated in the ifu, ¿the trufill n-butyl cyanoacrylate (n-bca) liquid embolic system is an artificial embolization device, comprised of trufill n-butyl cyanoacrylate (n-bca), trufill ethiodized oil and trufill tantalum powder.These components must be used as a system.They are not intended for use as individual components.The trufill ethiodized oil, (which was not used in this case), is used as a radiopaque polymerizing retardant.The amount of ethiodized oil used will vary the rate of polymerization¿.These instructions are followed by a bold letter warning for users: ¿do not use tantalum powder alone with n-bca¿.Additionally, the high blood flow of the targeted vessel is also a factor of this procedure that would preclude the safe administration of the product.Per the mso, without the use of ethiodized oil as a polymerization retardant the n-bca/tantalum mixture is expected to polymerize immediately on exiting the catheter once in contact with blood.This is well known and would thus account for the catheter becoming glued to the vessel wall and the subsequent vessel perforation resulting from attempted catheter removal by retraction pull force.It is likely that the effects of vessel perforation resulted in the series of observed events: respiratory distress, hemodynamic instability, and prolonged critical care hospitalization for the patient.Based on this information, this event meets us fda reporting criteria under 21 crf 803 with a classification of a ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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.

• Brand Name: TRUFILL N-BCA-1 GRAM KIT
• Type of Device: TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS, INC.; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17716139
• MDR Text Key: 323696106
• Report Number: 3008114965-2023-00621
• Device Sequence Number: 1
• Product Code: KGG
• UDI-Device Identifier: 10886704029151
• UDI-Public: 10886704029151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 631500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• 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
• Treatment: HEADWAY® DUO 167 MICROCATHETER (MICROVENTION).
• Patient Age: 12 DA