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	Thromboembolism (2654)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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 four products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00036, 3008114965-2020-00038 and 3008114965-2020-00039.Complaint conclusion: as reported by the sterling study, a (b)(6)-year old female (subject (b)(6)) underwent coil embolization of a ruptured left anterior cerebral artery (aca) bifurcation aneurysm on (b)(6) 2019 and experienced intraoperative aneurysm re-rupture after placing a 2.5mm x 5cm galaxy g3 xsft (glx122505/l13753) coil.The rupture resolved on the same day with temporary balloon occlusion and further coiling.Per the principal investigator (pi), the event was moderate in severity and was possibly related to the study device.There was also a thromboembolic event at the neck of the aneurysm (at the transition of the right anterior communicating artery and the a2 segment of the left aca).The patient was asymptomatic (only observed angiographically) and integrilin iib iiia was administered for 24-hours.On (b)(6) 2019, angiography revealed a ruptured aneurysm at the left aca bifurcation.The aneurysm height was 2.0mm and dome was 3.2mm.The maximum aneurysm diameter was 4.4mm, neck size was 3.1mm and dome-to-neck ratio was 1.0mm.The parent vessel diameter was 2.5mm.Coil embolization was subsequently performed with the implantation of one 4mm x 6cm galaxy g3 xsft (glx120406/l13761), one 2.5mm x 5cm galaxy g3 xsft (glx122505/l13753), one 2mm x 4cm galaxy g3 xsft hel (glx120204/l11992), one 2mm x 1.5cm galaxy g3 xsft (glx120201/ l11772), and two competitor coils via an excelsior sl-10 (stryker) microcatheter.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 of 59.8%.The post-procedure modified raymond-roy classification score was class ii (residual neck).There were no reported study device deficiencies.The patient was discharged to another hospital on (b)(6) 2019 with modified rankin scale (mrs) score of 0.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l13761 number, and no non-conformances related to the reported complaint condition were identified.Thromboembolism is a known potential complication associated with the use of the galaxy g3 coil in coil embolization procedures.Manipulation of devices in or near the intracranial aneurysm increases the risk of rupturing the fragile aneurysm wall.Studies have shown that the approximate rate of re-bleeding from a ruptured aneurysm within two weeks of the initial hemorrhage is 20-25%.The aneurysm wall is likely to be even more fragile following a bleed or subarachnoid hemorrhage.Re-rupture may occur within a short period due to vessel wall changes as a result of the initial rupture.Thrombus in the aneurysm, normal pulsations of blood transmitted through the mass, cellular ischemia related to the aneurysm formation and initial rupture are factors that can play a role in causing re-rupture.Aneurysm/vessel characteristics including shape, size, and location and percentage of the aneurysm occupied by coils are factors that may have contributed to stronger hemodynamic stress due to flow changes.These flow changes into the aneurysm with known vessel wall weakness may have contributed to the event.The file will be re-reviewed if additional information is received at a later date.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.
Event or Problem Description
As reported by the (b)(6), a (b)(6)-year old female (subject (b)(6)) underwent coil embolization of a ruptured left anterior cerebral artery (aca) bifurcation aneurysm on (b)(6) 2019 and experienced intraoperative aneurysm re-rupture after placing a 2.5mm x 5cm galaxy g3 xsft (glx122505/l13753) coil.The rupture resolved on the same day with temporary balloon occlusion and further coiling.Per the principal investigator (pi), the event was moderate in severity and was possibly related to the study device.There was also a thromboembolic event at the neck of the aneurysm (at the transition of the right anterior communicating artery and the a2 segment of the left aca).The patient was asymptomatic (only observed angiographically) and integrilin iib iiia was administered for 24-hours.On (b)(6) 2019, angiography revealed a ruptured aneurysm at the left aca bifurcation.The aneurysm height was 2.0mm and dome was 3.2mm.The maximum aneurysm diameter was 4.4mm, neck size was 3.1mm and dome-to-neck ratio was 1.0mm.The parent vessel diameter was 2.5mm.Coil embolization was subsequently performed with the implantation of one 4mm x 6cm galaxy g3 xsft (glx120406/l13761), one 2.5mm x 5cm galaxy g3 xsft (glx122505/l13753), one 2mm x 4cm galaxy g3 xsft hel (glx120204/l11992), one 2mm x 1.5cm galaxy g3 xsft (glx120201/ l11772), and two competitor coils via an excelsior sl-10 (stryker) microcatheter.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 of 59.8%.The post-procedure modified raymond-roy classification score was class ii (residual neck).There were no reported study device deficiencies.The patient was discharged to another hospital on (b)(6) 2019 with modified rankin scale (mrs) score of 0.

• 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: 9751393
• Report Number: 3008114965-2020-00034
• Device Sequence Number: 19600240
• Product Code: KRD
• UDI-Device Identifier: 10886704077725
• UDI-Public: 10886704077725
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: GLX120406
• Device Catalogue Number: GLX120406
• Device Lot Number: L13761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/25/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 65