MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 2.5MM X 3.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX122535
Medical Device Problem Codes	Separation Failure (2547); Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The initial reporter phone: (b)(6).The initial reporter email address is not available / reported.Conclusion: the healthcare professional reported that during a stent-assisted coil embolization procedure targeting a recurrent internal carotid (ic)-posterior communication artery (pc) aneurysm, a 2.5mm x 3.5cm galaxy g3 xsft coil (glx122535 / 30532642) failed to detach and then became unintendedly detached in the concomitant microcatheter (unspecified brand) at the time of retrieval.A 4.5mm x 21cm neuroform atlas® stent system (stryker) had been implanted, and one loop of the coil deviated from the stent and protruded into the parent vessel.An additional 4.5mm x 21cm neuroform atlas® stent system was implanted and the procedure was completed.The physician stated that he/she will follow-up with the patient with medical treatment.The complaint coil is not available to be returned for evaluation.On 22 dec 2021, additional information was received.The information indicated that there was no difficulty positioning the coil in the aneurysm.The protrusion into the parent vessel did not result in restriction of blood flow nor in thrombosis.There was no information about the coil being stretched when it was removed.When the coil became prematurely detached, one loop of the coil went over the stent to the vessel.The additional neuroform atlas stent implantation was related to the complaint coil becoming protruded into the parent vessel.The information indicated that a pre-deployment electrical check was performed.The fault light was not seen during the procedure, and upon pressing the power button, all the lights illuminated.The green system ready light illuminated and during the detachment cycle, the detachment light illuminated and the audible signal beep was heard.All connections fit without application of excessive force.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30532642) 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.Failure of the coil to detach, unintended detachment during retrieval, and coil protrusion into parent vessel are known potential complications associated with the use of galaxy g3 xsft in coil embolization procedures.Factors that can contribute to detachment issues include failure to confirm secure connection of the cable to the device positioning unit (dpu) and detachment control box (dcb).The instructions for use (ifu) advises the user to ensure that the connecting cable is fully seated with the connector end of the dpu wire and output connector of the dcb.The user should verify that the microcoil delivery system is fully connected and that no faults are indicated on the dcb.If a fault exists, all connections should be reseated between the dpu, the dcb, and the connecting cable.If a fault still persists, the connecting cable should be replaced.If this does not correct the error, the dcb should be replaced.If the microcoil delivery system still continues to have a fault, the microcoil should be retrieved and replaced with a new microcoil system.If after depressing the detach button on the dcb, the dcb should be replaced if the light and audible tone do not activate.Also, if the system ready light is not illuminated and there is no detachment after two detachment attempts, the dcb should be replaced.If detachment still does not occur, the microcoil system should be carefully withdrawn and replaced.Following failed coil detachment, it appears that the coil unintendedly detached in the microcatheter during retrieval and subsequently protruded into the parent vessel.Assignment of root cause for the event remains speculative and inconclusive without the return of the associated devices.However, there are clinical and procedural factors that may have contributed rather than the design or manufacture of the device.Since the event required additional intervention (i.E., placement of an additional stent) to preclude patient complications such as non-target site embolization, ischemia, or infarct, 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 healthcare professional reported that during a stent-assisted coil embolization procedure targeting a recurrent internal carotid (ic)-posterior communication artery (pc) aneurysm, a 2.5mm x 3.5cm galaxy g3 xsft coil (glx122535 / 30532642) failed to detach and then became unintendedly detached in the concomitant microcatheter (unspecified brand) at the time of retrieval.A 4.5mm x 21cm neuroform atlas® stent system (stryker) had been implanted, and one loop of the coil deviated from the stent and protruded into the parent vessel.An additional 4.5mm x 21cm neuroform atlas® stent system was implanted and the procedure was completed.The physician stated that he/she will follow-up with the patient with medical treatment.The complaint coil is not available to be returned for evaluation.On 22 dec 2021, additional information was received.The information indicated that there was no difficulty positioning the coil in the aneurysm.The protrusion into the parent vessel did not result in restriction of blood flow nor in thrombosis.There was no information about the coil being stretched when it was removed.When the coil became prematurely detached, one loop of the coil went over the stent to the vessel.The additional neuroform atlas stent implantation was related to the complaint coil becoming protruded into the parent vessel.The information indicated that a pre-deployment electrical check was performed.The fault light was not seen during the procedure, and upon pressing the power button, all the lights illuminated.The green system ready light illuminated and during the detachment cycle, the detachment light illuminated and the audible signal beep was heard.All connections fit without application of excessive force.

• Brand Name: GALAXY G3 XSFT 2.5MM X 3.5CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-8687
• MDR Report Key: 13145523
• Report Number: 3008114965-2021-00747
• Device Sequence Number: 14615452
• Product Code: KRD
• UDI-Device Identifier: 10886704077619
• UDI-Public: 10886704077619
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2022

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 Model Number: GLX122535
• Device Catalogue Number: GLX122535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEUROFORM ATLAS® STENT SYSTEM (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown