MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 3.5MM X 7.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY123575
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding the patient date of birth was not provided.Procode is krd/hcg.The initial reporter email address and phone number were not provided / reported.[conclusion]: the event was reported via the (b)(6) study, the (b)(6) year-old female with a past medical history of headaches underwent stent-assisted coil embolization of an unruptured left internal carotid artery (ica) bifurcation aneurysm on (b)(6) 2021.Immediate pre-procedure angiography revealed an anterior circulation aneurysm in the left ica.The unruptured aneurysm had the following dimensions: height 4.0mm, dome 3.5mm, maximum aneurysm diameter 4.0mm, neck size 2.4mm, and dome-to-neck ratio 1.5mm.The parent vessel diameter was 2.9mm.The neuroform atlas® stent system (stryker) stent-assisted coil embolization was subsequently performed with the implantation of one 3mm x 6cm galaxy g3 xsft (glx120306 / 30470347), two 2mm x 3cm galaxy g3 mini (glm920030 / 30407098 & 30401363), and one 1.5mm x 2cm galaxy g3 mini (glm915020 / 30366403).A phenom¿ 17 microcatheter (medtronic).Per the information documented in the case report form (crf), microcatheter kickback (loss of access to aneurysm) was experienced once during the procedure.Additionally, one 3.5mm x 7.5cm galaxy g3 (gly123575 / l17137) and one 1.5mm x 2cm galaxy g3 mini (glm915020 / 30392244) were used but not implanted.Heparin was administered during the procedure.In the opinion of the investigator, treatment of the target aneurysm was considered complete.Immediate post-procedure modified raymond-roy classification score was iiia (residual aneurysm with contrast within coil interstices).There were no reported intraoperative complications, such as aneurysm rupture or thromboembolic event.On 17 may 2021, additional information was received indicated that the physician encountered resistance during advancement of the 2mm x 3cm galaxy g3 mini (glm920030 / 30401363) coil.The exact location where the resistance was first felt is unknown; however, the event resulted in a loss of cerebral target position.On 21 june 2021, information was received from the study site.The information indicated that the principal investigator confirmed that the 2mm x 3cm galaxy g3 mini coil (glm920030 / 30401363) did encounter resistance / friction during advancement, but the coil could be implanted.The additional information indicated that there were two other coils, the 3.5mm x 7.5cm galaxy g3 (gly123575 / l17137) and the 1.5mm x 2cm galaxy g3 mini (glm915020 / 30392244), that also encountered resistance / friction during advancement; they were not used.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l17137) 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.Coil resistance / friction is a known procedural occurrence.Removal and exchange of devices is common routine practice in endovascular procedures.If resistance is encountered, the system being inserted should be withdrawn as a unit to prevent injury.With the information provided, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors that may have contributed rather than the design or manufacture of the device.Loss of target position in the intracranial vasculature will require re-accessing the target site with increased potential for vessel trauma, vessel spasm, and / or ischemia/infarct.Therefore, the event meets mdr reporting criteria.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: 3008114965-2021-00196, and 3008114965-2021-00257.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 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) year-old female with a past medical history of headaches underwent stent-assisted coil embolization of an unruptured left internal carotid artery (ica) bifurcation aneurysm on (b)(6) 2021.Immediate pre-procedure angiography revealed an anterior circulation aneurysm in the left ica.The unruptured aneurysm had the following dimensions: height 4.0mm, dome 3.5mm, maximum aneurysm diameter 4.0mm, neck size 2.4mm, and dome-to-neck ratio 1.5mm.The parent vessel diameter was 2.9mm.The neuroform atlas® stent system (stryker) stent-assisted coil embolization was subsequently performed with the implantation of one 3mm x 6cm galaxy g3 xsft (glx120306 / 30470347), two 2mm x 3cm galaxy g3 mini (glm920030 / 30407098 & 30401363), and one 1.5mm x 2cm galaxy g3 mini (glm915020 / 30366403).A phenom¿ 17 microcatheter (medtronic).Per the information documented in the case report form (crf), microcatheter kickback (loss of access to aneurysm) was experienced once during the procedure.Additionally, one 3.5mm x 7.5cm galaxy g3 (gly123575 / l17137) and one 1.5mm x 2cm galaxy g3 mini (glm915020 / 30392244) were used but not implanted.Heparin was administered during the procedure.In the opinion of the investigator, treatment of the target aneurysm was considered complete.Immediate post-procedure modified raymond-roy classification score was iiia (residual aneurysm with contrast within coil interstices).There were no reported intraoperative complications, such as aneurysm rupture or thromboembolic event.On 17 may 2021, additional information was received indicated that the physician encountered resistance during advancement of the 2mm x 3cm galaxy g3 mini (glm920030 / 30401363) coil.The exact location where the resistance was first felt is unknown; however, the event resulted in a loss of cerebral target position.On 21 june 2021, information was received from the study site.The information indicated that the principal investigator confirmed that the 2mm x 3cm galaxy g3 mini coil (glm920030 / 30401363) did encounter resistance / friction during advancement, but the coil could be implanted.The additional information indicated that there were two other coils, the 3.5mm x 7.5cm galaxy g3 (gly123575 / l17137) and the 1.5mm x 2cm galaxy g3 mini (glm915020 / 30392244), that also encountered resistance / friction during advancement; they were not used.

• Brand Name: GALAXY G3 3.5MM X 7.5CM
• 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: 12051329
• Report Number: 3008114965-2021-00256
• Device Sequence Number: 14555629
• Product Code: KRD
• UDI-Device Identifier: 10886704077435
• UDI-Public: 10886704077435
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: GLY123575
• Device Catalogue Number: GLY123575
• Device Lot Number: L17137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 51