MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL KIT, 1 GLUE, 1EA TA/OIL; TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS

Catalog Number 631500E

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

Patient Problem Headache (1880)

Event Date 08/09/2023

Event Type  Injury  

Event Description

As reported via the membrane study, a 54-year-old male (subject (b)(6)) with a medical history of headaches, covid 19 infection in dec 2022, peripheral vascular disease, and hypertension (controlled), underwent middle meningeal artery (mma) embolization of a right parietal subdural hematoma (sdh) with temporal, occipital, and frontal involvement on 04-aug-2023.The patient was randomized into the surgical and mma embolization cohort of the study.The patient¿s baseline markwalder grading scale (mgs) score was 1 and the modified rankin scale (mrs) score was 1.The sdh thickness was 17.9mm.The mma embolization study procedure was performed on 09-aug-2023 via right femoral access.Trufill n-bca 1x1 gram glue (631500e/ m0920d) (4:1 oil: n-bca ratio) was delivered beyond the midline via an echelon 10 microcatheter (microvention).The anterior and posterior branches of the mma were embolized.During the procedure, a vasospasm of the external carotid artery occurred, which lasted for one minute and was treated with medication.In the opinion of the treating physician, the embolization was successful.The patient was discharged on 11-aug-2023 with a mini-mental state exam (mmse) score of 28, a markwalder grading scale (mgs) score of 0, and a modified rankin scale (mrs) score of 0.On 09-aug-2023, the patient experienced the event of ¿headache (worsening from baseline)¿.The principal investigator (pi) assessed this event as moderate in severity, not serious, with a probable relationship to the study device, but not related to the mma embolization procedure, the medication used to treat the subdural hematoma (sdh), nor to the surgical procedure used to treat the sdh.The patient was medicinally treated with a flurbiprofen axetil injection, and the event is noted as ¿recovered/ resolved¿ with an end date of 09-aug-2023.

Manufacturer Narrative

Product complaint # (b)(4).Section a1: patient identifier - (b)(6).The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device m0920d number, and no non-conformances related to the malfunction were identified.Headaches is a known potential complication associated with the trufill n-bca liquid embolic system and are listed as such in the instructions for use (ifu).There were no alleged quality issues/ malfunctions related to the device, as the device performed as intended.However, the principal investigator assessed the event of ¿headache (worsening from baseline)¿ as having a probable relationship to the study device.The correlating relationship between the event and device remains plausible.Therefore, this event does meet us fda reporting criteria under 21 cfr 803.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.

• Brand Name: KIT, 1 GLUE, 1EA TA/OIL
• 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: 17698484
• MDR Text Key: 322829821
• Report Number: 3008114965-2023-00649
• Device Sequence Number: 1
• Product Code: KGG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 631500E
• Device Lot Number: M0920D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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: ECHELON 10 MICROCATHETER (MICROVENTION)
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian