MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 3MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120304
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); Hydrocephalus (3272)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The event was reported via the sterling study, a 68-year-old female patient with a history of ischemic stroke, headaches, controlled hyperlipidaemia, controlled hypertension, and hypothyroidism underwent coil embolization of an unruptured fusiform aneurysm on the sidewall of the left internal carotid artery (ica), with the parent artery location on c7 (communicating segment); the size of the target aneurysm is as follows: height 12.5mm, dome 9mm, maximum aneurysm diameter 12.5mm, neck size 2mm, and dome-to-neck ratio (derived) 4.5mm.The modified rankin scale (mrs) score of 2 on (b)(6) 2021.Coil embolization was performed and the following nine (9) cerenovus coils were delivered via an excelsior® sl-10® microcatheter (stryker) and implanted: a 7mm x 21cm galaxy g3 (gly120721 / 30399454), a 6mm x 15cm galaxy g3 (gly120615 / 30409555), a 4mm x 10cm galaxy g3 xsft (glx120410 / l15756), a 4mm x 8cm galaxy g3 xsft (glx120408 / l16656), a 3mm x 6cm galaxy g3 xsft (glx120306 / 30624678), a 3mm x 6cm galaxy g3 xsft (glx120306 / 30490139), a 3mm x 6cm galaxy g3 xsft (glx120306 / 30624678), a 3mm x 4cm galaxy g3 xsft (glx120304 / 30508852), and a 2.5mm x 5cm galaxy g3 xsft (glx122505 / l15552).Heparin was administered during the procedure.In the opinion of the investigator, the treatment of the target aneurysm was considered complete, with the study coils successfully implanted at the target site with a packing density without g3 mini coil (using angiosuite) of 10% and at the conclusion of the procedure (using angiosuite) of 10%.Immediate post-procedure modified raymond-roy classification score was class iiib: residual aneurysm with contrast along aneurysm wall.There were no reported study device deficiencies or intraoperative complications.The patient was discharged home on (b)(6) 2021 with a mrs score of 2.The 180-day (6-month) follow-up visit was performed in the clinic on (b)(6) 2022 with an mrs score of 2.Digital subtraction angiography (dsa) was performed and showed a modified raymond-roy classification class ii score; the status of the aneurysm did not change since the discharge, i.E.Not newly ruptured or re-ruptured aneurysm.The patient subsequently underwent aneurysm retreatment on (b)(6) 2022 due to a residual neck and an aneurysm increase in size.Surgical clipping was performed using a 5mm micro aneurysm clip (device information unknown).Modified raymond-roy classification score following retreatment was class i: complete obliteration.There were no reported intraoperative complications or aneurysm rupture.The patient was discharge to the rehabilitation center on (b)(6) 2023.With an mrs score of 4.The status of the aneurysm has been documented in the clinical database as did not change since the discharge, i.E.Not newly ruptured or re-ruptured aneurysm.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth was not reported.Procode is krd/hcg.The initial reporter phone and email address are not available / reported.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (30508852) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.A manufacturing documentation review was performed.There is no indication that the event is related to the device manufacturing process.Aneurysm recanalization is a condition requiring additional intervention or retreatment or can be reasonably expected to result in medical or surgical intervention, including hospitalization.Furthermore, the relationship of the study devices to the reported aneurysm recanalization cannot be excluded.Thus, the event is considered serious and mdr reportable.This file will be reassessed if new information becomes available.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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 is one of 9 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00078, 3008114965-2023-00079, 3008114965-2023-00080, 3008114965-2023-00081, 3008114965-2023-00082, 3008114965-2023-00083, 3008114965-2023-00084, and 3008114965-2023-00086.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to make a correction.Based on the additional information received on 01-mar-2023, there was coil compaction associated with all nine (9) coils.Coil compaction is usfda reportable under title 21 cfr 203 with a classification of ¿malfunction.¿ section b.1: ¿is product problem¿ box was not checked.This mdr submission is to check this box to document the malfunction that was captured and documented in section h.6: medical device problem code in the 3500a follow up number 1 report.Updated sections: b.1, b.4, g.3, g.6, h.2, h.10, and h.11.Corrected section: b.1.This is one of 9 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00078, 3008114965-2023-00079, 3008114965-2023-00080, 3008114965-2023-00081, 3008114965-2023-00082, 3008114965-2023-00083, 3008114965-2023-00084, and 3008114965-2023-00086.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.Section b.1: ¿is product problem¿ box was not checked.This mdr submission is to check this box to document the malfunction that was captured and documented in section h.6: medical device problem code in the 3500a follow up number 1 report.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 01-mar-2023 and modified information received on 02-mar-2023.[additional information]: responses to additional information requests were received on 01-mar-2023, from the sterling study clinical team.The information indicated that the coils remained within the aneurysm sac.There was evidence of coil compaction related to all nine (9) coils used.When the recanalization was diagnosed, the aneurysm was at 24% occlusion.The patient was symptomatic as a result of the recanalization; the aneurysm growth led to obstruction and the patient experienced hydrocephalus as a result.The hydrocephalus resolved after the placement of an external ventricular drain (evd).The aneurysm clip used was a 5mm titanium yasargil® aneurysm clip system (aesculap).Modified information was received from the sterling study clinical team on 02-mar-2023.The information is related to format edits of the case report form (crf); the modified information does not impact the complaint file.Aneurysm recanalization is a known potential adverse event associated with coil embolization procedures.Aneurysm recanalization is a condition requiring additional intervention or retreatment or can be reasonably expected to result in medical or surgical intervention, including hospitalization.The additional information received indicated that there was coil compaction associated with all nine (9) coils implanted with only 24% aneurysm occlusion at the time the recanalization was diagnosed.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.Return of blood flow into the aneurysm due to coil compaction may increase the risk for aneurysm rupture and possibly require additional intervention.The reported coil compaction and aneurysm recanalization caused aneurysm growth that led to obstruction and the patient experienced hydrocephalus that necessitated the placement of an external ventricular drain (evd) to alleviate the symptom and resolve the hydrocephalus.Therefore, the event is considered serious and usfda reportable under title 21 cfr 803 with a classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.This is one of 9 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00078, 3008114965-2023-00079, 3008114965-2023-00080, 3008114965-2023-00081, 3008114965-2023-00082, 3008114965-2023-00083, 3008114965-2023-00084, 3008114965-2023-00085, and 3008114965-2023-00086.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the modified information received on 07-may-2025.This mdr submission also includes the primary udi number of the complaint device.[modified information]: on 07-may-2025, modified information was received related to the date of the retreatment of target aneurysm.The date of treatment ¿(b)(6) 2022¿ has been changed to ¿(b)(6) 2022.¿ the manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the modified information received on 08-may-2025.[modified information]: on 08-may-2025, modified information was received related to the date of the retreatment of target aneurysm.The date of treatment has been from ¿1(b)(6) 2022¿ back to ¿(b)(6) 2022.¿ updated sections: b.4, g.3, g.6, h.2, and h.11.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: GALAXY G3 XSFT 3MM X 4CM
• 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): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 16368997
• Report Number: 3008114965-2023-00085
• Device Sequence Number: 12451828
• Product Code: KRD
• UDI-Device Identifier: 10886704077688
• UDI-Public: (01)10886704077688(17)231231(10)30508852
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/08/2025

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 Expiration Date: 12/31/2023
• Device Model Number: GLX120304
• Device Catalogue Number: GLX120304
• Device Lot Number: 30508852
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 03/01/2023; 03/01/2023; 05/07/2025; 05/08/2025
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/03/2023; 03/03/2023; 05/07/2025; 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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: EXCELSIOR® SL-10® MICROCATHETER (STRYKER).; GALAXY G3 6MM X 15CM.; GALAXY G3 7MM X 21CM.; GALAXY G3 XSFT 2.5MM X 5CM.; GALAXY G3 XSFT 3MM X 6CM.; GALAXY G3 XSFT 3MM X 6CM.; GALAXY G3 XSFT 3MM X 6CM.; GALAXY G3 XSFT 4MM X 10CM.; GALAXY G3 XSFT 4MM X 8CM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White