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 07/13/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, race, and ethnicity was not reported.Patient identifier: (b)(6).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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported via the membrane study, a 69-year-old female (subject (b)(6)) with a history of testing positive for covid 19 and subarachnoid hemorrhage (sah) underwent middle meningeal artery (mma) embolization of a left frontal subdural hematoma (sdh) on (b)(6)2022.The patient was randomized into the non-surgical medical management (nsmm) and mma embolization cohort of the study.The patient¿s baseline markwalder grading scale (mgs) score was 1 and modified rankin scale (mrs) score was 2.The sdh thickness was 21 mm and volume 64 ml.The mma embolization study procedure was performed via the right radial access.Trufill n-bca 1x1 gram glue (lot # jy1048) (4:1 oil: n-bca ratio) was delivered bilaterally via a headway duo (microvention).Coils were also implanted due to the inability to navigate the catheter to the appropriate n-bca injection position.In the opinion of the treating physician, the embolization was successful.On (b)(6) 2022 the patient experienced a frontal headache, which was assessed by the principal investigator as mild in severity, not serious, possibly related to the study device, possible related to the mma embolization study procedure, not related to the sdh medication, and not related to the surgical procedure used to treat the sdh.The event has.

Manufacturer Narrative

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported via the membrane study, a 69-year-old female (subject (b)(6)) with a history of testing positive for covid-19 and subarachnoid hemorrhage (sah) underwent middle meningeal artery (mma) embolization of a left frontal subdural hematoma (sdh) on 13-jul-2022.The patient was randomized into the non-surgical medical management (nsmm) and mma embolization cohort of the study.The patient¿s baseline markwalder grading scale (mgs) score was 1 and modified rankin scale (mrs) score was 2.The sdh thickness was 21mm and volume 64ml.The mma embolization study procedure was performed via the right radial access.Trufill n-bca 1x1 gram glue (lot # jy1048) (4:1 oil: n-bca ratio) was delivered bilaterally via a headway duo (microvention).Coils were also implanted due to the inability to navigate the catheter to the appropriate n-bca injection position.In the opinion of the treating physician, the embolization was successful.On 13-jul-2022 the patient experienced a frontal headache, which was assessed by the principal investigator as mild in severity, not serious, possibly related to the study device, possible related to the mma embolization study procedure, not related to the sdh medication, and not related to the surgical procedure used to treat the sdh.The event has resolved, and the patient recovered on 14-jul-2022.The patient was discharged on 14-jul-2022 with a mini-mental state exam score of 26, a markwalder grading scale score of 0, and a modified rankin scale score of 2.The device is not available for analysis; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device jy1048 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 and to the mma embolization study procedure.Therefore, the event meets mdr reporting criteria with the classification of ¿serious injury¿.The file will be re-reviewed if additional information is received at a later date.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.

• 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 02767
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15184369
• MDR Text Key: 297444624
• Report Number: 3008114965-2022-00531
• 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
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 631-500
• Device Catalogue Number: 631500
• Device Lot Number: JY1048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• 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)
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR