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

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

Patient Problem Headache (1880)

Event Date 03/04/2023

Event Type  Injury  

Event Description

As reported via the membrane (b)(4) study, a 64-year-old male (b)(6) with a history of cardiac arrhythmia, congestive heart failure, coronary artery disease, chronic renal failure, a covid 19 positive, diabetes, hypertension (controlled) and previous smoker, underwent middle meningeal artery (mma) embolization of a right fronto-temporal subdural hematoma (sdh) on (b)(4)2023.The patient was randomized into the surgery + mma embolization cohort of the study.The patient¿s baseline glasgow coma scale (gcs) score was 14, mini mental state exam (mmse) score was 23.Markwalder grading scale (mgs) score was 2 and modified rankin scale (mrs) score was 3.The sdh thickness was 20.9mm.The mma embolization study procedure was performed via right femoral access.Trufill n-bca 1x1 gram glue (catalog: 631500/lot: jp3682), (4:1 oil: n-bca ratio) was delivered 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.On (b)(4) 2023 the patient experienced an worsened headache, which was assessed by the principal investigator as moderate in severity, not serious.Possibly related to the study device, possible related to the mma embolization study procedure, possibly to the surgical procedure used to treat the sdh, and not related to the sdh medication.The event has been medically treated (unknow medication) and patient outcome has been recorded as recovering/resolving.The patient was discharged on (b)(4) 2023 with a mini mental state exam score of 22.A markwalder grading scale score of 1.And a modified rankin scale score of 4.

Manufacturer Narrative

Product complaint # (b)(4).Patient identifier: (b)(6).The device was implanted, therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device jp3682 number, and no non-conformances related to the malfunction were identified.Headache is a known potential complication associated with the use of the trufill (n-bca) liquid embolic system and is listed in the instructions for use (ifu) as such.According to the information provided, the device performed as intended, and no new patient consequences have occurred related to the use of the device.However, the principal investigator assessed the event as possibly related to the study device, to the mma embolization study procedure.Therefore, this event is usfda reportable under 21 cfr 803 with a classification of ¿serious injury.The file will be re-reviewed if additional information is received at a later date.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.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).Section b5: additional information received on 26-may-2023.Summary of additional information provided: the patient¿s headache was reported as "recovered/resolved" with an end date of (b)(6) 2023.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).Updated section on this medwatch report: b4, b5, g3, g6, h2 and h10.Modified information received on 20-jun-2023.Summary of modified information provided: the patient¿s headache end date was changed on the crf from ¿06 mar 202306¿ to ¿blank¿ and outcome value was changed from recovered/resolved" to "not recovered/not resolved".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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16618642
• MDR Text Key: 312286559
• Report Number: 3008114965-2023-00197
• 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: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 631-500
• Device Catalogue Number: 631500
• Device Lot Number: JP3682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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 (MICROVENTION) MICROCATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White