MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 3CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM915030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.[conclusion]: the event was reported via the sterling study, a 29-year-old male patient (subject (b)(6) with no relevant medical history, underwent coil embolization of a ruptured, side wall, right anterior choroidal artery (acha) aneurysm with a hunt & hess grade 3, modified rankin scale (mrs) score 0 on (b)(6) 2022.The dimension of the aneurysm was as follows: height 3.2mm, dome 1.8mm, maximum aneurysm diameter 1.9mm, neck size 1.3mm, and dome-to-neck ratio of 1.4mm.The parent vessel diameter was 0.6mm.Platelet reactivity testing was not performed.Per the case report form (crf) and the clinical study database, the coil embolization was performed with a 1.50mm x 3.00cm galaxy g3 mini coil (glm915030 / l14712) via an excelsior® sl-10® microcatheter (stryker).Heparin was administered during the procedure.In the opinion of the principal investigator (pi), the treatment of the target aneurysm was considered complete.The study coil was successfully implanted at the target site with a packing density without g3 mini coil (using angiosuite) was 0% and at the conclusion of the procedure (using angiosuite) was 21%.A balloon catheter (unspecified brand) was also used.Immediate post-procedure modified raymond-roy classification score was class ii.There were no reported study device deficiencies or intraoperative complications.The patient was discharged to home on (b)(6) 2022 with a modified rankin scale (mrs) score of 3.The 180-day (6-month) follow-up visit was performed in the clinic on (b)(6) 2022 with a modified rankin scale (mrs) score of 0.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 patient was discharged (i.E., no newly ruptured or re-ruptured aneurysm).The patient subsequently underwent aneurysm retreatment on (b)(6) 2022 due to a residual neck using a surpass evolve¿ flow diverter (stryker) at the right internal carotid artery (ica).Modified raymond-roy classification score following retreatment was class i: complete obliteration.There were no reported intraoperative complications during the retreatment intervention.The patient was discharged to home on (b)(6) 2022.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (l14712) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As a result, the investigation will be closed.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 device 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 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.
Event or Problem Description
The event was reported via the sterling study, a 29-year-old male patient (subject (b)(6) with no relevant medical history, underwent coil embolization of a ruptured, side wall, right anterior choroidal artery (acha) aneurysm with a hunt & hess grade 3, modified rankin scale (mrs) score 0 on (b)(6) 2022.The dimension of the aneurysm was as follows: height 3.2mm, dome 1.8mm, maximum aneurysm diameter 1.9mm, neck size 1.3mm, and dome-to-neck ratio of 1.4mm.The parent vessel diameter was 0.6mm.Platelet reactivity testing was not performed.Per the case report form (crf) and the clinical study database, the coil embolization was performed with a 1.50mm x 3.00cm galaxy g3 mini coil (glm915030 / l14712) via an excelsior® sl-10® microcatheter (stryker).Heparin was administered during the procedure.In the opinion of the principal investigator (pi), the treatment of the target aneurysm was considered complete.The study coil was successfully implanted at the target site with a packing density without g3 mini coil (using angiosuite) was 0% and at the conclusion of the procedure (using angiosuite) was 21%.A balloon catheter (unspecified brand) was also used.Immediate post-procedure modified raymond-roy classification score was class ii.There were no reported study device deficiencies or intraoperative complications.The patient was discharged to home on 25-feb-2022 with a modified rankin scale (mrs) score of 3.The 180-day (6-month) follow-up visit was performed in the clinic on (b)(6) 2022 with a modified rankin scale (mrs) score of 0.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 patient was discharged (i.E., no newly ruptured or re-ruptured aneurysm).The patient subsequently underwent aneurysm retreatment on (b)(6) 2022 due to a residual neck using a surpass evolve¿ flow diverter (stryker) at the right internal carotid artery (ica).Modified raymond-roy classification score following retreatment was class i: complete obliteration.There were no reported intraoperative complications during the retreatment intervention.The patient was discharged to home on (b)(6) 2022.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 25-jan-2023.[additional information]: on 25-jan-2023, responses to additional information request was received.The additional information indicated that all coils remained within the aneurysm sac.There was no evidence of coil compaction.More than 85% of the aneurysm was occluded when the recanalization was diagnosed.The patient was not symptomatic.The residual filling of the neck was discovered on routine imaging.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 MINI 1.5MM X 3CM
• 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: 16185657
• Report Number: 3008114965-2023-00039
• Device Sequence Number: 14118535
• Product Code: KRD
• UDI-Device Identifier: 10886704080145
• UDI-Public: 10886704080145
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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: 01/31/2022
• Device Model Number: GLM915030
• Device Catalogue Number: GLM915030
• Device Lot Number: L14712
• 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: 12/29/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• 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)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 80 KG