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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Confusion/ Disorientation (2553)

Event Date 11/10/2023

Event Type  Injury  

Event Description

As reported via the membrane study, an 82-year-old female (subject (b)(6)) with a medical history of coronary artery disease and hypertension (controlled), underwent middle meningeal artery (mma) embolization of a left frontal subdural hematoma (sdh) with temporal and parietal involvement on (b)(6) 2023.The patient was randomized into the non-surgical and mma embolization cohort of the study.The patient¿s baseline markwalder grading scale (mgs) score was 0 and the modified rankin scale (mrs) score was 0.The sdh thickness was 11.The mma embolization study procedure was performed on (b)(6) 2023 via right femoral access.Trufill n-bca-1 gram kit (631500/m4378t) (4:1 oil: n-bca ratio) was delivered to midline via a headway duo (microvention).The anterior and posterior branches of the mma were embolized.In the opinion of the treating physician, the embolization was successful.The event of ¿increased confusion,¿ which started on 10-nov-2023, was assessed by the pi as a serious, severe adverse event, and as not related to the study device, possibly related to the mma embolization procedure, not related to the medication used to treat the subdural hematoma (sdh), and possibly related to the surgical procedure used to treat the sdh.The event required the diagnostic test of a ct brain.The outcome is recorded as ¿not recovered/not resolved.¿ the event of ¿punctate acute stroke left corona radiata,¿ which started on (b)(6) 2023, was assessed by the pi as a serious, severe adverse event, and as not related to the study device, possibly related to the mma embolization procedure, not related to the medication used to treat the subdural hematoma (sdh), and possibly related to the surgical procedure used to treat the sdh.The event was treated with medication.The outcome is recorded as ¿recovering/resolving.¿ the patient was discharged from the hospital on (b)(6) 2023 with a mini-mental state exam (mmse) score of 8, a markwalder grading scale (mgs) score of 2, and a modified rankin scale (mrs) score of 4.

Manufacturer Narrative

Product complaint # (b)(4).Device manufacture date: not available at the time of report.Stroke and neurological deficits, such as confusion, are both known potential complications associated with the use of the trufill n-bca liquid embolic agent and is mentioned in the instructions for use (ifu) as such.There were no alleged quality issues/ malfunctions related to the device, as the device performed as intended.The events of ¿increased confusion and punctate acute stroke left corona radiata¿ were both assessed by the pi as unrelated to the study device but possibly related to the mma embolization study procedure and possibly related to the surgical procedure used to treat the sdh.In patients of advanced age (82-year-old), increased confusion can be attributed to the urinary tract infection (uti), however, should be resolved once the infection resolves.In this case, it was reported that the uti resolved with an end date of (b)(6) 2023, while the confusion did not.The events were assessed as possibly related to the mma embolization study procedure (with n-bca), and the relationship of the device to the reported events, although remote, based on the principal investigator's assessment of not related, cannot be excluded as a factor in the events.Therefore, the events of stroke and confusion will be conservatively reported to the us fda reporting under criteria 21 cfr 803 with a classification of ¿serious injury.¿ as part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.Reference: dutta c, pasha k, paul s, abbas ms, nassar st, tasha t, desai a, bajgain a, ali a, mohammed l.Urinary tract infection induced delirium in elderly patients: a systematic review.Cureus.2022 dec 8;14(12):e32321.Doi: 10.7759/cureus.32321.Pmid: 36632270; pmcid: pmc9827929.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.

Manufacturer Narrative

Product complaint # (b)(4).The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device m4378t number, and no non-conformances related to the malfunction were identified.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional/modified information was received on 10-jan-2024.Summary: regarding the adverse event of ¿increased confusion,¿ the severity value of "severe" has been changed to "moderate." a supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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 ; 3035526892
• MDR Report Key: 18239745
• MDR Text Key: 329429511
• Report Number: 3008114965-2023-00878
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 631500
• Device Lot Number: M4378T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2023
• 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; Life Threatening
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White