MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 3MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM930060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Patient identifier - (b)(6).Procode: krd/hcg.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of six products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00460, 3008114965-2020-00461, 3008114965-2020-00463, 3008114965-2020-00464 and 3008114965-2020-00465.
Event or Problem Description
As reported via the (b)(6) study, a (b)(6) year old female (subject (b)(6) with a history of focal neurological deficits, headaches, smoking (current), and intracranial aneurysms (total of 4) presented with a subarachnoid hemorrhage (hunt & hess grade 2) and subsequently underwent coil embolization of a ruptured posterior communicating artery bifurcation aneurysm on (b)(6) 2020.Immediate pre-procedure angiography revealed a ruptured right posterior communicating artery bifurcation aneurysm with the following dimensions: height 3.3mm, dome 5.7mm, maximum aneurysm diameter 7.8mm, neck size 4.3mm, and dome-to-neck ratio 1.3mm.The parent vessel diameter was 3.4mm.Coil embolization was subsequently performed with the implantation of one 4mm x 10cm galaxy g3 xsft (glx120410/l16657), one 3mm x 8cm galaxy g3 mini (glm930080/l13408), two 3mm x 6cm galaxy g3 mini (glm930060/l14489 & l12012), one 2mm x 6cm galaxy g3 mini (glm920060/l16340), and one 2mm x 4cm galaxy g3 mini (glm920040/l15998) via an echelon 10 (medtronic) microcatheter.The patient experienced a thromboembolic event at an unspecified time during the procedure which resolved with medication.The patient was reportedly asymptomatic; the event was only observed angiographically.The study coils were successfully implanted at the target site with 49% angiosuite packing density.In the opinion of the investigator, treatment of the target aneurysm was considered complete with modified raymond-roy score of 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.Platelet reactivity testing was not performed.The patient was discharged home with self-care on (b)(6) 2020 with modified rankin scale (mrs) score of 1.180-day (6-month) follow-up digital subtraction angiography (dsa) performed on (b)(6) 2020 demonstrated modified raymond-roy class i: complete obliteration.Mrs score was 0.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported via the sterling study, a 63-year old female (subject 972-004) with a history of focal neurological deficits, headaches, smoking (current), and intracranial aneurysms (total of 4) presented with a subarachnoid hemorrhage (hunt & hess grade 2) and subsequently underwent coil embolization of a ruptured posterior communicating artery bifurcation aneurysm on (b)(6) 2020.Immediate pre-procedure angiography revealed a ruptured right posterior communicating artery bifurcation aneurysm with the following dimensions: height 3.3mm, dome 5.7mm, maximum aneurysm diameter 7.8mm, neck size 4.3mm, and dome-to-neck ratio 1.3mm.The parent vessel diameter was 3.4mm.Coil embolization was subsequently performed with the implantation of one 4mm x 10cm galaxy g3 xsft (glx120410/l16657), one 3mm x 8cm galaxy g3 mini (glm930080/l13408), two 3mm x 6cm galaxy g3 mini (glm930060/l14489 & l12012), one 2mm x 6cm galaxy g3 mini (glm920060/l16340), and one 2mm x 4cm galaxy g3 mini (glm920040/l15998) via an echelon 10 (medtronic) microcatheter.The patient experienced a thromboembolic event at an unspecified time during the procedure which resolved with medication.The patient was reportedly asymptomatic; the event was only observed angiographically.The study coils were successfully implanted at the target site with 49% angiosuite packing density.In the opinion of the investigator, treatment of the target aneurysm was considered complete with modified raymond-roy score of 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.Platelet reactivity testing was not performed.The patient was discharged home with self-care on (b)(6) 2020 with modified rankin scale (mrs) score of 1.180-day (6-month) follow-up digital subtraction angiography (dsa) performed on (b)(6) 2020 demonstrated modified raymond-roy class i: complete obliteration.Mrs score was 0.The device remains implanted and therefore is no available for investigation.A manufacturing record evaluation was performed for the finished device l14489 number, and no non-conformances related to the reported complaint condition were identified.Cerebral thrombosis is a known potential adverse event associated with coil embolization procedures.With the information provided, it is not possible to determine the root cause of the thrombotic event; however, there are clinical and pharmacological factors including this patient¿s pre-procedure presentation with a ruptured aneurysm that may have contributed to the event.There have been studies showing evidence for a generalized strong activation of the coagulation and fibrinolytic system in patients with subarachnoid hemorrhage.Based on the available information, there is no indication of any device performance or manufacturing issues related to the reported event.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.

• Brand Name: GALAXY G3 MINI 3MM 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: 10677707
• Report Number: 3008114965-2020-00462
• Device Sequence Number: 2954847
• Product Code: KRD
• UDI-Device Identifier: 10886704080336
• UDI-Public: 10886704080336
• 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: foreign,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: GLM930060
• Device Catalogue Number: GLM930060
• Device Lot Number: L14489
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON 10 (MEDTRONIC) MICROCATHETER; GALAXY G3 MINI 2MM X 4CM; GALAXY G3 MINI 2MM X 6CM; GALAXY G3 MINI 3MM X 6CM; GALAXY G3 MINI 3MM X 8CM; GALAXY G3 XSFT 4MM X 10CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR