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

Catalog Number	GLX123575
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: hosomoto k, kuriyama m, hirotsune n, terasaka k.Endovascular coiling for a ruptured middle cerebral artery-lenticulostriate artery bifurcation aneurysm suspected to be a pseudoaneurysm: a case report.Nmc case rep j.2024 oct 11;11:267-272.Doi: 10.2176/jns-nmc.2024-0102.Pmid: 39479471; pmcid: pmc11524614.Objective and methods: this article presented to report a successful used of coil embolization to treat a ruptured aneurysm that was considered to be a pseudoaneurysm located at the mca-lsa bifurcation.A 43-year-old woman was treated with cardiopulmonary arrest due to a subarachnoid hemorrhage.A right middle cerebral artery-lenticulostriate artery bifurcation aneurysm was detected, which was suspected to be a pseudoaneurysm.The aneurysmal shape changed dynamically, probably because of thrombus formation and resolution.Delayed cerebral vasospasm was also observed.A simple coil embolization using three detachable coils such (1) 3.5 mm × 7.5 cm galaxy g3 xsft (cerenovus, irvine, ca, usa), (2) 2mm × 3 cm target nano (stryker), and (3) 1.5 mm × 2 cm target nano was performed.Close follow-up is crucial and important after the procedure.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: 3.5 mm × 7.5 cm galaxy g3 xsft.Other cerenovus devices that were also used in this study: no other cnv devices mentioned non-cerenovus devices that were also used in this study: 2mm × 3 cm target nano (stryker), and (3) 1.5 mm × 2 cm target nano.Adverse event(s) and provided interventions: -dsa at 26 days from onset showed recurrence of the mca-lsa aneurysm and coil compaction but ct presented no evidence of rebleeding, and cerebral vasospasm was absent.Endovascular intervention was carried out again at 34 days from onset under general anesthesia.After the procedure, there was no periprocedural complication detected.Head ct angiography at 47 days from onset showed no recurrence of the aneurysm.The patient had mild left hemiparesis and mild cognitive dysfunction, scored 3 on the modified rankin scale, and was transferred to the rehabilitation hospital 48 days after onset.Her hemiparesis resolved within a month, but the cognitive dysfunction remained.She was discharged to home 138 days after onset with a score of 2 on the modified rankin scale.Dsa at 6 months from onset revealed that the good obliteration of mca-lsa aneurysm was maintained and the lsa branches were preserved.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Section d2b: procode: krd/hcg.Section d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Section h4: the device manufacture date is not known as the device lot number is not available / not reported.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Clinician assessment: although competitor devices were used, one of the used coils is identified as a cerenovus device; therefore, the cerenovus device cannot be disassociated from the adverse event of aneurysm recanalization secondary to coil compaction.Since the event required surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.The event is reportable to the us fda.The complaint will be updated with any additional information received from performing follow-up activity with the corresponding author, and reportability for the us fda will be reassessed.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: 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 21942993
• Report Number: 3008114965-2025-00404
• Device Sequence Number: 15587106
• Product Code: KRD
• UDI-Device Identifier: 10886704077664
• UDI-Public: (01)10886704077664
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: GLX123575
• 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: 04/21/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: TARGET NANO® EMBOLIC COILS (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female