MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 4MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120406
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.(b)(6).[conclusion]: the healthcare professional reported that during a coil embolization of an internal carotid artery (ica) aneurysm, a 4mm x 6cm galaxy g3 xsft coil (glx120406 / 30504555) was detached as the first coil to frame the aneurysm sac.The delivery wire of the coil was fully removed from the patient.The physician then attempted to advance a second coil (size / brand / manufacturer not specified) but strong resistance was encountered at the tip of the concomitant excelsior® sl-10® microcatheter (stryker).As a result of this phenomenon, the physician removed the second coil and advanced the guidewire to push the first 4mm x 6cm galaxy g3 xsft coil that was stuck near the tip of the microcatheter.Finally, the first coil was successfully advanced into the target aneurysm.The second coil was also able to be advanced into the target aneurysm.The procedure was successfully completed.There was no report of any delay in the procedure due to the reported event.No fragments were generated.There was no report of any patient injury or complication.The 4mm x 6cm galaxy g3 xsft coil remains implanted and is thus, not available to be returned.On 27 july 2021, additional information was received.The information indicated that the target aneurysm was 4mm in size and saccular in shape.The vessel was moderately tortuous.The second coil used during the procedure was a competitor (axium) coil.There was reportedly no evidence of coil entanglement/anchoring or coil protrusion into parent vessel.The competitor coil was able to be fully advanced after using a guidewire to push the complaint coil into the aneurysm.The physician verified proper positioning/alignment of the coil and marker band via fluoroscopy prior to detaching the complaint coil.There was no blood flow restriction/reduction as a result of the event.Procedural imaging is not available for review.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (30504555) 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 entanglement requiring additional intervention is a known potential procedural complication associated with the galaxy g3 xsft coil.Based on the information available for review and without films of the event, it is not possible to determine the root cause of the event.However, it appears that the second coil (competitor) became anchored with the previously implanted 4mm x 6cm galaxy g3 xsft coil that was obstructing the distal tip of the microcatheter.This phenomenon prevented further advancement of the second coil and required use of a guidewire to push the coil into the aneurysm.Per the galaxy g3 xsft instructions for use (ifu): to obtain proper positioning of the microcoil system for detachment under fluoroscopic guidance, align the radiopaque marker on the dpu wire just past the proximal marker band on the tip of the microcatheter.Once the desired microcoil placement has been achieved, gently tighten the rhv around the dpu wire to maintain its position.The position of the microcoil within the aneurysm and the detachment zone position should be re-verified via fluoroscopy prior to detachment.Assignment of root cause for the event remains speculative and inconclusive without procedural films and the return of the associated devices.However, there are clinical and procedural factors including aneurysm/vessel characteristics, device manipulation, device interaction, device selection, and operator technique that may have contributed to the event rather than the design or manufacture of the device.Since the alleged device issue necessitated use of a guidewire to push the coil into the aneurysm (i.E., surgical intervention) and preclude patient complications, the event meets mdr reporting criteria with the classification of ¿serious injury.¿ 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.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 healthcare professional reported that during a coil embolization of an internal carotid artery (ica) aneurysm, a 4mm x 6cm galaxy g3 xsft coil (glx120406 / 30504555) was detached as the first coil to frame the aneurysm sac.The delivery wire of the coil was fully removed from the patient.The physician then attempted to advance a second coil (size / brand / manufacturer not specified) but strong resistance was encountered at the tip of the concomitant excelsior® sl-10® microcatheter (stryker).As a result of this phenomenon, the physician removed the second coil and advanced the guidewire to push the first 4mm x 6cm galaxy g3 xsft coil that was stuck near the tip of the microcatheter.Finally, the first coil was successfully advanced into the target aneurysm.The second coil was also able to be advanced into the target aneurysm.The procedure was successfully completed.There was no report of any delay in the procedure due to the reported event.No fragments were generated.There was no report of any patient injury or complication.The 4mm x 6cm galaxy g3 xsft coil remains implanted and is thus, not available to be returned.On 27 july 2021, additional information was received.The information indicated that the target aneurysm was 4mm in size and saccular in shape.The vessel was moderately tortuous.The second coil used during the procedure was a competitor (axium) coil.There was reportedly no evidence of coil entanglement/anchoring or coil protrusion into parent vessel.The competitor coil was able to be fully advanced after using a guidewire to push the complaint coil into the aneurysm.The physician verified proper positioning/alignment of the coil and marker band via fluoroscopy prior to detaching the complaint coil.There was no blood flow restriction/reduction as a result of the event.Procedural imaging is not available for review.

• 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: 12239457
• Report Number: 3008114965-2021-00325
• Device Sequence Number: 17255162
• Product Code: KRD
• UDI-Device Identifier: 10886704077725
• UDI-Public: 10886704077725
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K150319
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 12/31/2023
• Device Model Number: GLX120406
• Device Catalogue Number: GLX120406
• Device Lot Number: 30504555
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/28/2021
• 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: EXCELSIOR® SL-10® MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention