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

Catalog Number	GLX123509
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via the sterling study, a 41-year-old female (subject (b)(6)) with a history of headaches and previous smoking, presented with an unruptured aneurysm, and subsequently underwent coil embolization on (b)(6) 2023.Immediate pre-procedure angiography revealed an unruptured aneurysm on the left bifurcation anterior circulation: internal carotid artery (ica): height: 4.0mm, dome: 4.7mm, maximum aneurysm diameter: 4.7mm, neck size: 1.9mm, and dome-to-neck ratio: 2.5mm.The parent vessel diameter was 3.4mm.Platelet reactivity testing was not performed pre-procedure.Coil embolization was performed with the implantation of one galaxy g3 xsft 3.5mm x 9cm (glx123509 / 30637474) via a headway 17 microcatheter (microvention).Heparin was administered during the procedure.The study coil was 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 i: complete = complete obliteration.There were no device deficiencies.On (b)(6) 2023, the patient was discharged home for self-care with a modified rankin scale (mrs) score of 0.On (b)(6) 2024, the patient was assessed via phone for the 180-day (6 month) follow-up visit, for which magnetic resonance angiography (mra) was not performed, however, the modified rankin scale (mrs) assessment was performed which resulted in a score of 1.On (b)(6) 2024, the patient was assessed via phone for the 180-day (6 month) follow-up visit, for which magnetic resonance angiography (mra) was performed and revealed a modified raymond-roy classification of class iiib: residual aneurysm with contrast along aneurysm wall.The modified rankin scale (mrs) assessment resulted in a score of 0.On (b)(6) 2024, the patient experienced the event of ¿target aneurysm recanalization,¿ which became known to the site on (b)(6) 2024 and to the sponsor on (b)(6) 2024.The principal investigator (pi) assessed the event as a serious adverse event, moderate in severity, and as probably related to the study device.In the opinion of investigator, the event was expected/anticipated.The event requires endovascular intervention: ¿probable future additional embolization.¿ the outcome is recorded as ¿recovering/resolving.¿.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section a1.Patient identifier: (b)(6).Section d2b ¿ procode: krd/hcg.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30637474 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 device, as the device 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.Since the event of aneurysm recanalization was assessed as a serious adverse event that will require an additional surgical intervention to preclude patient harm, this event does meet us fda reporting criteria under 21 crf 803 with the classification of a ¿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.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this med watch report: b4, b5, g3, g6, h2, h6 (health effect, impact code) and h11.Section b5: additional/modified information was received on 13-jan-2025.Summary: regarding the adverse event of ¿target aneurysm recanalization,¿ the answer field for ¿endovascular intervention¿ was updated from "yes" has been changed to "no." the answer field for ¿medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function¿ was updated from "yes" has been changed to "no." ¿if endovascular intervention, specify¿ was updated from "probable future additional embolization" to "embolization." ¿is the adverse event serious?¿ value "yes" has been changed to "no." ¿if diagnostic tests/evaluations, specify¿ value "[blank]" has been changed to "cerebral arteriography." ¿if endovascular intervention, specify¿ value "embolization" has been changed to "[blank]." per the additional/modified information received on 13-jan-2025, the endovascular intervention of ¿embolization¿ has been removed from the clinical database.The event of ¿target aneurysm recanalization¿ required the diagnostic evaluation of a "cerebral arteriography.¿ based on this information, the health effect, impact code: ¿surgical intervention¿ has been replaced with ¿hospitalization for further diagnosis.¿ no further changes to the file were required.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4).Per the additional/modified information received on 22-jan-2025, the adverse event of ¿target aneurysm recanalization,¿ the event was made inactive on the clinical database.The reason for inactivating the event is unknown.Nevertheless, the event is to be considered void.Therefore, this event is no longer reportable to the usfda.The file will be re-reviewed if additional information is received at a later date.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint (b)(4).Section b5: per the additional information received on 27-jan-2025, the investigator considered the adverse event of ¿target aneurysm recanalization¿ to be not serious, and thus, did not meet reporting criteria per the study¿s protocol.However, since the event required the diagnostic test of a cerebral arteriography (invasive procedure) and prolonged hospitalization, the event of ¿target aneurysm recanalization¿ does meet us fda reporting criteria under 21 crf 803 with the classification of a ¿serious injury,¿ with an awareness date of 27-jan-2025.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Updated sections on this medwatch: b4, b5, g3, g6, h2, h6 (medical device problem code) and h11.Section b5: additional information was received on 04-feb-2025.Summary: a device deficiency was reported for the used galaxy g3 xsft 3.5mm x 9cm (glx123509 / 30637474)."04 oct 2024, mri shows aneurysm recanalization due to coil compaction." per the additional information received on 04-feb-2025, a device malfunction was reported for the used galaxy g3 xsft coil.Coil compaction is the decrease in interspaces between the loops of the coils, which leads to smaller coil mesh.It occurs over time after coil placement.Coil compaction presents risk to the patient, as return of blood flow into the aneurysm may increase the risk for aneurysm rupture and possibly require additional intervention.In this case, the event resulted in reoccurrence of the aneurysm which required the diagnostic test of a cerebral arteriography (invasive procedure) and prolonged hospitalization.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: 20534360
• Report Number: 3008114965-2024-01038
• Device Sequence Number: 6641771
• Product Code: KRD
• UDI-Device Identifier: 10886704077671
• UDI-Public: (01)10886704077671(17)240731(10)30637474
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/12/2025

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: 07/31/2024
• Device Catalogue Number: GLX123509
• Device Lot Number: 30637474
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 01/22/2025; 01/27/2025; 02/04/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 01/14/2025; 01/27/2025; 02/04/2025; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY 17 MICROCATHETER (MICROVENTION).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 48 KG