MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 4MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).A1.Patient identifier: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of five products involved with the complaint and the associated manufacturer report numbers are 3008114965-2021-00058, 3008114965-2021-00059, 3008114965-2021-00060 and 3008114965-2021-00061.Complaint conclusion: as reported via the (b)(6) study, a (b)(6) year old female (subject (b)(6)) with a history of being a current smoker underwent coil embolization of a left side wall posterior communicating artery (pca) (anterior circulation) aneurysm on (b)(6) 2019.Immediate pre-procedure angiography revealed a ruptured left pca aneurysm with the following dimensions: height 5.1mm, dome 3.3mm, maximum aneurysm diameter 5.1mm, neck size 2.0mm, and dome-to-neck ratio 1.7mm.The parent vessel diameter was 3.2mm.Coil embolization was subsequently performed with the implantation of one 4mm x 6cm galaxy g3 xsft (glx120406/l16293), one 2mm x 2cm galaxy g3 (gly120202/l12097), one 3mm x 8cm galaxy g3 mini (glm930080/l12616), one 1.5mm x 2cm galaxy g3 mini (glm915020/l11355), and one 1mm x 1cm galaxy g3 mini (glm910010/l14466) via an excelsior sl-10 (stryker) microcatheter.The study coils were successfully implanted at the target site with 24.09% angiosuite packing density.According to the case report form (crf), there was no reported microcatheter kickback.In the opinion of the investigator, treatment of the target aneurysm was considered complete with modified raymond-roy score of class i: complete = complete obliteration.There were no reported intraoperative adverse events or study device deficiencies.The patient was discharged home with skilled nursing care on (b)(6) 2019 with a mrs score of 1.During the patient¿s 1 year follow up, the patient underwent retreatment of the target aneurysm on (b)(6) 2020 due to residual aneurysm.The type of retreatment that the patient underwent was an implantation of a pipeline (medtronic) flow diverter.Modified raymond-roy classification for the target aneurysm following retreatment was class ii: residual neck = persistence of any portion of the original defect of the arterial wall but without opacification of the aneurysmal sac.The patient was discharged home with self-care on (b)(6) 2020.Additional information received from the clinical site on (b)(6) 2021 indicated that the physician believes that the aneurysm being ruptured when initially treated and having a small neck (which is common) contributed to the event of recanalization.The percentage of aneurysm occlusion was 80-90% when the recanalization was diagnosed.The patient was not symptomatic as a result of the recanalization.Lastly, there was no evidence of compaction of the coils that were implanted at the time of initial target aneurysm treatment on (b)(6) 2019.The device remains implanted and thus is not available for investigation.A manufacturing record evaluation was performed for the finished device l16293 number, and no non-conformances related to the reported complaint condition were identified aneurysm recanalization is a known potential complication associated with coil embolization procedures.Review of the available information does not allow for an exact determination of root cause; however, factors which may have a correlation with recanalization following coil embolization include neck size, packing density, and inflow angle.The file will be re-reviewed if additional information is received at a later date.S 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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.
Event or Problem Description
As reported via the (b)(6) study, a (b)(6) year old female (subject (b)(6)) with a history of being a current smoker underwent coil embolization of a left side wall posterior communicating artery (pca) (anterior circulation) aneurysm on (b)(6) 2019.Immediate pre-procedure angiography revealed a ruptured left pca aneurysm with the following dimensions: height 5.1mm, dome 3.3mm, maximum aneurysm diameter 5.1mm, neck size 2.0mm, and dome-to-neck ratio 1.7mm.The parent vessel diameter was 3.2mm.Coil embolization was subsequently performed with the implantation of one 4mm x 6cm galaxy g3 xsft (glx120406/l16293), one 2mm x 2cm galaxy g3 (gly120202/l12097), one 3mm x 8cm galaxy g3 mini (glm930080/l12616), one 1.5mm x 2cm galaxy g3 mini (glm915020/l11355), and one 1mm x 1cm galaxy g3 mini (glm910010/l14466) via an excelsior sl-10 (stryker) microcatheter.The study coils were successfully implanted at the target site with 24.09% angiosuite packing density.According to the case report form (crf), there was no reported microcatheter kickback.In the opinion of the investigator, treatment of the target aneurysm was considered complete with modified raymond-roy score of class i: complete = complete obliteration.There were no reported intraoperative adverse events or study device deficiencies.The patient was discharged home with skilled nursing care on (b)(6) 2019 with a mrs score of 1.During the patient¿s 1 year follow up, the patient underwent retreatment of the target aneurysm on (b)(6) 2020 due to residual aneurysm.The type of retreatment that the patient underwent was an implantation of a pipeline (medtronic) flow diverter.Modified raymond-roy classification for the target aneurysm following retreatment was class ii: residual neck = persistence of any portion of the original defect of the arterial wall but without opacification of the aneurysmal sac.The patient was discharged home with self-care on (b)(6) 2020.Additional information received from the clinical site on 13-jan-2021 indicated that the physician believes that the aneurysm being ruptured when initially treated and having a small neck (which is common) contributed to the event of recanalization.The percentage of aneurysm occlusion was 80-90% when the recanalization was diagnosed.The patient was not symptomatic as a result of the recanalization.Lastly, there was no evidence of compaction of the coils that were implanted at the time of initial target aneurysm treatment on (b)(6)2019.

• Brand Name: GALAXY G3 XSFT 4MM X 6CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11236973
• Report Number: 3008114965-2021-00057
• Device Sequence Number: 11832113
• Product Code: KRD
• UDI-Device Identifier: 10886704077725
• UDI-Public: 10886704077725
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2021

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: 06/30/2022
• Device Model Number: GLX120406
• Device Catalogue Number: GLX120406
• Device Lot Number: L16293
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 64