MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 3MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM930040
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Aneurysm (1708); No Code Available (3191)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, and weight, were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.(b)(6).[conclusion]: the event was reported via the (b)(6) study, the (b)(6) female patient with a history of hydrocephalus presented with a subarachnoid hemorrhage (hunt & hess grade 2) and subsequently underwent coil embolization of a ruptured posterior inferior cerebellar artery (pica) aneurysm on (b)(6) 2020.Immediate pre-procedure angiography revealed a left pica bifurcation aneurysm with the following dimensions: height 5.0mm, dome 3.3mm, maximum aneurysm diameter 5.0mm, neck size 2.3mm, and dome-to-neck ratio 1.4mm.The parent vessel diameter was 3.0mm.The patient subsequently underwent coil embolization and the following coils were delivered and implanted via the phenom¿ 17 microcatheter (medtronic): one 3mm x 4cm galaxy g3 mini (glm930040 / l12914), one 2mm x 6cm galaxy g3 mini (glm920060 / l11063), and one 1mm x 4cm galaxy g3 mini (glm910040 / l11000).In the opinion of the investigator, the treatment of the target aneurysm was considered complete and the study coils were successfully implanted at the target site with angiosuite packing density 24%.Immediate post-procedure modified raymond-roy classification score was class iiia: residual aneurysm with contrast within coil interstices.The reason additional coils were not placed was due to ¿risk to lose the access¿ and ¿satisfying aneurysm protection¿.There were no reported intraoperative complications or study device deficiencies.The patient was discharged home with self-care on (b)(6) 2020 with modified rankin scale (mrs) score of 0.She was seen in the clinic on (b)(6) 2020 for the 180-day (6-month) follow-up visit.Digital subtraction angiography (dsa) demonstrated class iiib: residual aneurysm with contrast along aneurysm wall.Therefore, the patient underwent retreatment of the target aneurysm with a flow diverter on (b)(6) 2020.Mrs score was 0.Additional information was received on 09 october 2020 indicated that an optimal aneurysm occlusion was not reached during the index procedure due to the use of galaxy g3 coils.They were reportedly ¿too stiff¿ and the galaxy g3 mini coils ¿have very low volume¿ resulting in low packing densities.The ¿unusual minimal¿ coil compaction prompted the need for aneurysm retreatment.Modified information was received on 13 october 2020.The modified raymond-roy classification for the target aneurysm following treatment was class i: complete obliteration.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (l12914) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Aneurysm recanalization is a known potential complication associated with coil embolization procedures.Coil compaction is the decrease in interspaces between the loops of the coils, which leads to smaller coil mesh.It can occur over time after coil placement.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.Since the alleged coil compaction with aneurysm recanalization necessitated re-treatment to prevent further injury or complications.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 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2020-00452, 3008114965-2020-00453, and 3008114965-2020-00454.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 (b)(6) study, the (b)(6) female patient with a history of hydrocephalus presented with a subarachnoid hemorrhage (hunt & hess grade 2) and subsequently underwent coil embolization of a ruptured posterior inferior cerebellar artery (pica) aneurysm on (b)(6) 2020.Immediate pre-procedure angiography revealed a left pica bifurcation aneurysm with the following dimensions: height 5.0mm, dome 3.3mm, maximum aneurysm diameter 5.0mm, neck size 2.3mm, and dome-to-neck ratio 1.4mm.The parent vessel diameter was 3.0mm.The patient subsequently underwent coil embolization and the following coils were delivered and implanted via the phenom¿ 17 microcatheter (medtronic): one 3mm x 4cm galaxy g3 mini (glm930040 / l12914), one 2mm x 6cm galaxy g3 mini (glm920060 / l11063), and one 1mm x 4cm galaxy g3 mini (glm910040 / l11000).In the opinion of the investigator, the treatment of the target aneurysm was considered complete and the study coils were successfully implanted at the target site with angiosuite packing density 24%.Immediate post-procedure modified raymond-roy classification score was class iiia: residual aneurysm with contrast within coil interstices.The reason additional coils were not placed was due to ¿risk to lose the access¿ and ¿satisfying aneurysm protection¿.There were no reported intraoperative complications or study device deficiencies.The patient was discharged home with self-care on (b)(6) 2020 with modified rankin scale (mrs) score of 0.She was seen in the clinic on (b)(6) 2020 for the 180-day (6-month) follow-up visit.Digital subtraction angiography (dsa) demonstrated class iiib: residual aneurysm with contrast along aneurysm wall.Therefore, the patient underwent retreatment of the target aneurysm with a flow diverter on (b)(6) 2020.Mrs score was 0.Additional information was received on 09 october 2020 indicated that an optimal aneurysm occlusion was not reached during the index procedure due to the use of galaxy g3 coils.They were reportedly ¿too stiff¿ and the galaxy g3 mini coils ¿have very low volume¿ resulting in low packing densities.The ¿unusual minimal¿ coil compaction prompted the need for aneurysm retreatment.Modified information was received on 13 october 2020.The modified raymond-roy classification for the target aneurysm following treatment was class i: complete obliteration.

• Brand Name: GALAXY G3 MINI 3MM X 4CM
• 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: 10729232
• Report Number: 3008114965-2020-00452
• Device Sequence Number: 3061038
• Product Code: KRD
• UDI-Device Identifier: 10886704080329
• UDI-Public: 10886704080329
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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: 05/31/2021
• Device Model Number: GLM930040
• Device Catalogue Number: GLM930040
• Device Lot Number: L12914
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/23/2020
• 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: 51 YR