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	Distress (2329)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, race, and ethnicity was not reported.Patient identifier: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported via the membrane study, an (b)(6) male (subject (b)(6) with a history of a head injury within the past 12 months, hydrocephalus, and smoking underwent middle meningeal artery (mma) embolization of a right subdural hematoma (sdh) on (b)(6) 2022.The patient was randomized into the surgery + mma embolization cohort of the study.His baseline glasgow coma scale (gcs) score was 14, mini mental state exam (mmse) score was 12, markwalder grading scale (mgs) score was 2 and modified rankin scale (mrs) score was 2.The hematoma thickness was 18.3 mm on the baseline ct scan.Surgery was performed on (b)(6) 2022.One burr hole was drilled into the right side of the frontal and parietal skull and a subgaleal drain was placed.The mma embolization study procedure was performed on (b)(6) 2022 using right femoral access.Trufill n-bca 1x1 gram (631500/jd4687) (4:1 oil: n-bca ratio) was delivered via a headway duo microcatheter (microvention).The anterior & posterior branches of the mma were embolized.There was no vasospasm noted during the procedure.In the opinion of the treating physician, the embolization was successful.Additional information received indicated that patient experienced post-anesthesia agitation, which was treated with 195 ug of dexmedetomidine and two-point restraint.The patient recovered and event was resolved on (b)(6) 2022.The principal investigator-assessed this event as moderate in severity, non-serious, not related to the study device, probably related to the mma embolization procedure with n-bca, not related to the sdh medication or to the surgical procedure used to treat the sdh.
Additional Manufacturer Narrative
Product complaint # (b)(4).The adverse event ¿distress (e020203)¿ does not meet regulatory reporting criteria.The reported event was assessed by the principal investigator-assessed as not related to the device, but probably related to the mma embolization procedure with n-bca, the event meets does not meet mdr reporting criteria.Therefore, no further medwatch reports will be forthcoming.

• 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 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 ; 646591-7981
• MDR Report Key: 14376255
• Report Number: 3008114965-2022-00333
• Device Sequence Number: 13955427
• Product Code: KGG
• UDI-Device Identifier: 10886704029151
• UDI-Public: 10886704029151
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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 Expiration Date: 07/31/2022
• Device Model Number: 631-500
• Device Catalogue Number: 631500
• Device Lot Number: JD4687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic