MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM915020
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No:(b)(4).Procode is krd/hcg.The event was reported via the sterling study, a 71-year-old male patient with a history of class 2 obesity (bmi 35 kg/m2) underwent coil embolization of a ruptured left anterior communicating artery (acom) aneurysm with hunt & hess grade 1 on (b)(6) 2021.The dimensions of the aneurysm were as follows: aneurysm height 5.9mm, dome 3.5mm, maximum aneurysm diameter 5mm, neck size 2.4mm, and dome-to-neck ratio of 1.5mm.The parent vessel diameter was 1.9mm.Coil embolization was performed with six cerenovus spectra coils: a 5 mm x 15 cm galaxy g3 (gly120515 / 30513182), a 3 mm x 8 cm galaxy g3 xsft (glx120308 / l14664), a 3 mm x 6 cm galaxy g3 xsft (glx120306 / 30490139), a 2 mm x 6 cm galaxy g3 mini (glm920060 / 30392250), a 1.5 mm x 2 cm galaxy g3 mini (glm915020 / l14683), and a 2 mm x 4 cm (glm920040 / 30379814) via an sl-10® microcatheter (stryker).Microcatheter kickback (loss of access to aneurysm) was experienced three times during the procedure.Heparin was administered intraoperatively.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 69% angiosuite packing density.Immediate post-procedure modified raymond-roy classification score was class ii: residual neck = persistence of any portion of the original defect of the arterial wall but without opacification of the aneurysmal sac.There were no reported study device deficiencies or intraoperative complications.The patient was discharged home with self-care on 07-oct-2021.On (b)(6) 2022, he underwent aneurysm retreatment due to residual neck.Coils (unspecified) and a 3mm x 21mm atlas stent (stryker) were implanted with final modified raymond-roy classification score of class i: complete obliteration.On the following day, the patient developed transient speech impairment.Head computed tomography (ct) scan was obtained and no acute findings were noted.Symptoms resolved later that day.Per the principal investigator (pi), the event was moderate in severity and not related to the study device.The event was not considered serious.The patient was discharged to a rehabilitation center on (b)(6) 2022.The complaint coils remain implanted in the patient and are thus not available for evaluation.On 11-apr-2022, additional information was provided.The information indicated that the aneurysm was found to have filling of the neck and body at follow-up angiography.Recanalization was diagnosed at 60% aneurysm occlusion.The coils remained in the aneurysm sac.There was evidence of coil compaction.The patient did not experience any clinical symptoms as a result of the aneurysm recanalization.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (l14683) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.As a result, we are closing this investigation.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 necessitated endovascular retreatment to preclude permanent damage or injury.Furthermore, the relationship of the study coils to the reported event cannot be excluded (i.E., coil compaction).Thus, the event is considered serious and mdr reportable for all implanted cerenovus coils.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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 6 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00240, 3008114965-2022-00241, 3008114965-2022-00242, 3008114965-2022-00243.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.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 71-year-old male patient with a history of class 2 obesity (bmi 35 kg/m2) underwent coil embolization of a ruptured left anterior communicating artery (acom) aneurysm with hunt & hess grade 1 on (b)(6) 2021.The dimensions of the aneurysm were as follows: aneurysm height 5.9mm, dome 3.5mm, maximum aneurysm diameter 5mm, neck size 2.4mm, and dome-to-neck ratio of 1.5mm.The parent vessel diameter was 1.9mm.Coil embolization was performed with six cerenovus spectra coils: a 5 mm x 15 cm galaxy g3 (gly120515 / 30513182), a 3 mm x 8 cm galaxy g3 xsft (glx120308 / l14664), a 3 mm x 6 cm galaxy g3 xsft (glx120306 / 30490139), a 2 mm x 6 cm galaxy g3 mini (glm920060 / 30392250), a 1.5 mm x 2 cm galaxy g3 mini (glm915020 / l14683), and a 2 mm x 4 cm (glm920040 / 30379814) via an sl-10® microcatheter (stryker).Microcatheter kickback (loss of access to aneurysm) was experienced three times during the procedure.Heparin was administered intraoperatively.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 69% angiosuite packing density.Immediate post-procedure modified raymond-roy classification score was class ii: residual neck = persistence of any portion of the original defect of the arterial wall but without opacification of the aneurysmal sac.There were no reported study device deficiencies or intraoperative complications.The patient was discharged home with self-care on (b)(6) 2021.On (b)(6) 2022, he underwent aneurysm retreatment due to residual neck.Coils (unspecified) and a 3mm x 21mm atlas stent (stryker) were implanted with final modified raymond-roy classification score of class i: complete obliteration.On the following day, the patient developed transient speech impairment.Head computed tomography (ct) scan was obtained and no acute findings were noted.Symptoms resolved later that day.Per the principal investigator (pi), the event was moderate in severity and not related to the study device.The event was not considered serious.The patient was discharged to a rehabilitation center on (b)(6) 2022.The complaint coils remain implanted in the patient and are thus not available for evaluation.On 11-apr-2022, additional information was provided.The information indicated that the aneurysm was found to have filling of the neck and body at follow-up angiography.Recanalization was diagnosed at 60% aneurysm occlusion.The coils remained in the aneurysm sac.There was evidence of coil compaction.The patient did not experience any clinical symptoms as a result of the aneurysm recanalization.

• Brand Name: GALAXY G3 MINI 1.5MM 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14078957
• Report Number: 3008114965-2022-00244
• Device Sequence Number: 2097038
• Product Code: KRD
• UDI-Device Identifier: 10886704080138
• UDI-Public: 10886704080138
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171862
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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: 12/31/2021
• Device Model Number: GLM915020
• Device Catalogue Number: GLM915020
• Device Lot Number: L14683
• 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: 03/25/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2019
• 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: GALAXY G3 5MM X 15CM; GALAXY G3 MINI 2MM X 4CM; GALAXY G3 MINI 2MM X 6CM; GALAXY G3 XSFT 3MM X 6CM; GALAXY G3 XSFT 3MM X 8CM; SL-10® MICROCATHETER (STRYKER); SYNCHRO2® 0.014¿ GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White