MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 2MM X 2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the sterling study, a 50-year-old female patient (b)(6) with a history of subarachnoid hemorrhage (sah) (target aneurysm), underwent coil embolization of a ruptured midline anterior communicating artery (acoa) bifurcation aneurysm with hunt & hess grade 2, modified rankin scale (mrs) score 0 on (b)(6) 2021.The dimension of the aneurysm was as follows: height 6mm, dome 4mm, maximum aneurysm diameter 4mm, neck size 2.5mm, and dome-to-neck ratio of 1.6mm.The parent vessel diameter was 2mm.Coil embolization was performed with two (2) cerenovus coils: a 2mm x 2cm galaxy g3 xtrasoft (glx120202/l12961) and a galaxy g3 xtrasoft 4mm x 8cm (glx120408/l12875) via a phenom 17 microcatheter.In the opinion of the investigator, treatment of the target aneurysm was considered complete, and the study coils were successfully implanted at the target site with 14.52% angiosuite packing density.Immediate post-procedure modified raymond-roy classification score was class i: complete obliteration.There were no reported study device deficiencies or intraoperative complications.The patient was discharged to home on (b)(6) 2021 with an mrs = 0.180-day (6-month) follow-up visit was performed in-clinic on (b)(6) 2022.Patient mrs score = 1.Magnetic resonance angiography (mra) was performed at (b)(6) 2022 but outcome and modified raymond-roy classification score is presently unknown.1-year follow-up visit was performed on (b)(6) 2022.Patient mrs score = 0.A new mra was performed on (b)(6) 2022 showing a modified raymond-roy classification score of class i: complete obliteration.The status of the target aneurysm has not changed since the previous visit (newly ruptured or re-ruptured).The complaint coils remain implanted in the patient and are thus not available for evaluation.The patient subsequently underwent aneurysm retreatment on (b)(6) 2022 due to aneurysm increase in size, nonruptured.Clip aneurysm mini 7mm perm (unspecified brand) was implanted.Modified raymond-roy classification score following retreatment was class i: complete obliteration.The patient was discharged to home on (b)(6) 2022.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient medical history, and ethnicity was not reported.Patient identifier: (b)(6).Procode: krd/hcg.The device remains implanted, therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l12961 number, and no non-conformances related to the reported complaint condition 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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00001 and 3008114965-2023-00002.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).Section b5: additional information was received on 24-jan-2022.Summary of additional information provided: it was stated that the physician doesn¿t know what caused or contributed to the event.It was mentioned that the patient had left eye pain complaints with some vision loss and there was concern for mass effect from the aneurysm on the optic apparatus.It was confirmed that the coils remain within the aneurysm sac.It was reported that the patient is doing well, with no objective complaint; however, it was stated that the patient feels now right eye getting worse compared to before, whereas the left eye is better.It was reported that there are no residual symptoms, at 1 year follow up the patient is doing well, the vision has improved, can drive now with no overall complaints.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 cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.

• Brand Name: GALAXY G3 XSFT 2MM X 2CM
• 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 ; 3035526892
• MDR Report Key: 16087175
• Report Number: 3008114965-2023-00001
• Device Sequence Number: 2020698
• Product Code: KRD
• UDI-Device Identifier: 10886704077640
• UDI-Public: 10886704077640
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 02/01/2023

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: 05/31/2021
• Device Model Number: GLX120202
• Device Catalogue Number: GLX120202
• Device Lot Number: L12961
• 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: 12/09/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• 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 XSFT 2MM X 2CM; PHENOM 17 MICROCATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Race: Asian