MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 2.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLM915025
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via the sterling registry (b)(6) , catheter angioplasty demonstrated coil compaction with a galaxy g3 mini coil 1.5mm x 2.5cm (glm915025, 30383043) as well as coil migration with a single loop that has migrated separately from the coil body and into the ostium of the left a2 segment.The device deficiency did not result in a serious adverse event.This was a coil embolization to a ruptured target aneurysm at the left anterior communicating artery with a 1.3mm parent vessel diameter, 5mm height and 3mm dome.The maximum aneurysm diameter was 3.5mm, neck size was 1.3mm and the dome to neck ration was 2.3mm.The coil remains implanted.Two study galaxy g3 mini 2.5mm x 5.5cm coil and a galaxy g3 4mm x 7cm coil were also successfully implanted.There was no kickback experienced.
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 30383043 number, and no non-conformances related to the malfunction were identified.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 company is seeking this information through the event investigation.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).Complaint conclusion: as reported via the sterling registry (cnv_2017_01: 01248-005), catheter angioplasty demonstrated coil compaction with a galaxy g3 mini coil 1.5mm x 2.5cm (glm915025, 30383043) as well as coil migration with a single loop that has migrated separately from the coil body and into the ostium of the left a2 segment.The device deficiency did not result in a serious adverse event.This was a coil embolization to a ruptured target aneurysm at the left anterior communicating artery with a 1.3mm parent vessel diameter, 5mm height and 3mm dome.The maximum aneurysm diameter was 3.5mm, neck size was 1.3mm and the dome to neck ration was 2.3mm.The coil remains implanted.Two study galaxy g3 mini 2.5mm x 5.5cm coil and a galaxy g3 4mm x 7cm coil were also successfully implanted.There was no kickback experienced.No additional information is available.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30383043 number, and no non-conformances related to the malfunction were identified.Coil migration and coil compaction are known potential adverse events associated with the use of the device.Review of the available information does not allow for an exact determination of root cause; however, factors which may have a correlation with coil embolization include neck size, packing density, and inflow angle.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
Product complaint # (b)(4).Updated sections on this medwatch: b1, b2, b4, b5, g3, g6, h1, h2, h6 and h10.Section b5: additional information was received on 21-mar-2024.Summary: per the additional information, the coil compaction was treated with the implantation of a small vessel flow diversion device, fred x (microvention) on (b)(6) 2023.The patient was not symptomatic.The percentage of occlusion following the initial procedure was ¿complete.¿ the percentage of occlusion when coil compaction was discovered and/or treated was ¿rr class2 (raymond¿roy occlusion classification class ii: residual neck).¿ there was no blood flow restriction/reduction as a result of the events.No additional intervention is planned.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 and may result in the return of blood flow into the aneurysm, which can increase the risk for aneurysm rupture and possibly require additional intervention.Coil migration, or movement of the detached coil away from the implant site, could result in non-target site embolization, ischemia, or infarct, or may require additional intervention.In this case, the events required an additional surgical intervention of implanting of a small vessel flow diversion device.Based on the additional intervention required to preclude patient harm, this event does meet us fda reporting criteria under 21 cfr 803 with a classification of ¿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.

• Brand Name: GALAXY G3 MINI 1.5MM X 2.5CM
• 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: 18464150
• Report Number: 3008114965-2024-00013
• Device Sequence Number: 3087825
• Product Code: KRD
• UDI-Device Identifier: 10886704080121
• UDI-Public: 10886704080121
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: GLM915025
• Device Lot Number: 30383043
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/12/2024; 03/21/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/12/2024; 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2020
• 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: GALAXY G3 4MM X 7CM; GALAXY G3 MINI 2.5MM X 5.5CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White