MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLM920060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Section a1.Patient identifier: (b)(6) section d2b ¿ procode: krd/hcg.The device remains implanted, therefor, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no non-conformances related to the malfunction were identified.Aneurysm recanalization is a known potential complication associated with coil embolization procedures.There was no alleged quality issue related to the used devices, as the devices performed as intended.There may have been procedural, patient, and pharmacological factors that contributed to the residual aneurysm with no indication of a device malfunction or defect.Factors which may have a correlation with recanalization following coil embolization include neck size, packing density, and inflow angle.Although there was no alleged quality issues related to the used devices, the event of aneurysm recanalization required an additional surgical intervention to preclude patient harm.Based on this information, this event does meet us fda reporting criteria under 21 crf 803 with the classification of a ¿serious injury,¿ with an awareness date of 18-nov-2024.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.
Event or Problem Description
As reported via the sterling study, a 60-year-old male (subject (b)(6)) with a medical history of controlled hyperlipidemia, headaches, controlled hypertension, presented with an unruptured aneurysm, and subsequently underwent coil embolization on (b)(6) 2024.Immediate pre-procedure angiography revealed an unruptured aneurysm on the right bifurcation anterior circulation: middle cerebral artery (mca): height: 4mm, dome: 2mm, maximum aneurysm diameter: 3.9mm, neck size: 2.8mm, and dome-to-neck ratio: 0.7mm.The parent vessel diameter was 3.2mm.Platelet reactivity testing was not performed pre-procedure.Coil embolization was performed with the implantation of one galaxy g3 xsft 3mm x 8cm (glx120308/ 30670800), one galaxy g3 mini 2mm x 6cm (glm920060/ 30830574), one galaxy g3 mini 2mm x 6cm (glm920060/ 30830574), one galaxy g3 mini 2.5mm x 5.5cm (glm925055/ 30599732), and one galaxy g3 mini 1.5mm x 2.5cm (glm915025/ 30797241) via an excelsior sl-10 microcatheter (stryker).Two neuroform atlas stents (stryker) were implanted as well.Heparin was administered during the procedure.The study coils were successfully implanted at the target site.In the opinion of the investigator, treatment of the target aneurysm was considered complete with modified raymond-roy classification score of class ii: residual neck (persistence of any portion of the original defect of the arterial wall but without opacification of the aneurysmal sac).It is unknown if there were any device deficiencies.On (b)(6) 2024, the patient was discharged home for self-care with a modified rankin scale (mrs) score of 0.On (b)(6) 2024, the patient was seen in-clinic for the 180-day (6 month) follow-up visit, for which digital subtraction angiography (dsa) was performed resulting in a modified raymond-roy classification score of class ii: residual neck (persistence of any portion of the original defect of the arterial wall but without opacification of the aneurysmal sac).The modified rankin scale (mrs) assessment was performed which resulted in a score of 0.On (b)(6) 2024, the patient underwent retreatment using two target tetra coils (stryker) for residual aneurysm.The retreatment was not related to a device-related serious adverse event.The retreatment of the target aneurysm was considered complete with modified raymond-roy classification score of class i: complete (complete obliteration).The patient was discharged home for self-care on (b)(6) 2024.

• Brand Name: GALAXY G3
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20857077
• Report Number: 3008114965-2024-01184
• Device Sequence Number: 17122993
• Product Code: KRD
• UDI-Device Identifier: 10886704077701
• UDI-Public: (01)10886704077701(17)250531(10)30830574
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

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: 05/31/2025
• Device Catalogue Number: GLM920060
• Device Lot Number: 30830574
• 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: 11/18/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEUROFORM ATLAS® STENT SYSTEM (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White