MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 4MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120408
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The healthcare professional reported that during a pulserider-assisted coil embolization of an unruptured aneurysm on the anterior communicating artery (acom), the guiding catheter (gc), an 8f optimo guiding catheter (tokai medical) was guided to the right internal carotid artery (ica) via the right femoral artery (fa) approach.The sofia ¿ 5f distal access catheter (microvention) was guided to the c1 segment of the ica, from which the prowler select plus microcatheter (catalog / lot# unknown) and a headway® 17 microcatheter (microvention) were inserted.The prowler select plus microcatheter was advanced to the a1 segment ¿ anterior cerebral artery (aca).A pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / lot# unknown) was implanted in a hybrid position.The headway® 17 microcatheter made the approach toward the aneurysm via trans-cell technique and coil embolization was initiated.The complaint coil, a 4mm x 8cm galaxy g3 xsft (glx120408 / 30701280) was used, but it became protruded to the neck side.The issue was not resolved despite rewinding several times.The coil was removed once from the patient¿s body.The position of the headway® 17 microcatheter i the aneurysm was changed.It was reported that the complaint coil could not be used and be re-sheathed because the introducer sheath had been damaged during the first attempt.A new 4mm x 8cm galaxy g3 xsft (glx120408) was opened and implanted in the aneurysm.After that, additional coils were added, a total of 19 coils (g3, g3 xsft, and g3 mini) were implanted and coil embolization was completed.The pulserider anrd was detached and final contrast imaging was performed.It was at that time that a slight thrombus was confirmed at the a2 segment of the aca.After activating clotting time (act) was measured and confirmed, antiplatelet agent ozagrel was administered intravenously.The physician waited for 15 minutes and confirmed that the thrombus had disappeared, the procedure was deemed completed.It was reported that continuous flush was maintained.There was no post-operative issue / problem detected in the patient.
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 name, phone and email address of the initial reporter are not available / reported.Conclusion: the healthcare professional reported that during a pulserider-assisted coil embolization of an unruptured aneurysm on the anterior communicating artery (acom), the guiding catheter (gc), an 8f optimo guiding catheter (tokai medical) was guided to the right internal carotid artery (ica) via the right femoral artery (fa) approach.The sofia ¿ 5f distal access catheter (microvention) was guided to the c1 segment of the ica, from which the prowler select plus microcatheter (catalog / lot# unknown) and a headway® 17 microcatheter (microvention) were inserted.The prowler select plus microcatheter was advanced to the a1 segment ¿ anterior cerebral artery (aca).A pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / lot# unknown) was implanted in a hybrid position.The headway® 17 microcatheter made the approach toward the aneurysm via trans-cell technique and coil embolization was initiated.The complaint coil, a 4mm x 8cm galaxy g3 xsft (glx120408 / 30701280) was used, but it became protruded to the neck side.The issue was not resolved despite rewinding several times.The coil was removed once from the patient¿s body.The position of the headway® 17 microcatheter i the aneurysm was changed.It was reported that the complaint coil could not be used and be re-sheathed because the introducer sheath had been damaged during the first attempt.A new 4mm x 8cm galaxy g3 xsft (glx120408) was opened and implanted in the aneurysm.After that, additional coils were added, a total of 19 coils (g3, g3 xsft, and g3 mini) were implanted and coil embolization was completed.The pulserider anrd was detached and final contrast imaging was performed.It was at that time that a slight thrombus was confirmed at the a2 segment of the aca.After activating clotting time (act) was measured and confirmed, antiplatelet agent ozagrel was administered intravenously.The physician waited for 15 minutes and confirmed that the thrombus had disappeared, the procedure was deemed completed.It was reported that continuous flush was maintained.There was no post-operative issue / problem detected in the patient.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30701280) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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 protrusion into parent vessel is a known potential complication associated with the use of embolic coils in endovascular embolization of intracranial aneurysms and is listed in the instructions for use (ifu) as such.Coil protrusion into parent vessel could result in non-target site embolization, ischemia, or infarct or may require additional intervention.In addition, medication was given to treat the cerebral thrombosis; a known potential adverse event associated with coil embolization procedures.Therefore, the event meets mdr reporting criteria with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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: 3008114965-2023-00091, and 3008114965-2023-00092.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 10-mar-2023.[additional information]: on 10-mar-2023, limited additional information was received.The information indicated that the lot number of the pulserider anrd could not be obtained; the catalog and lot numbers of the other 18 coils used could not be obtained.There were no issues with the 18 coils.Anonymized images / angiographs of the procedure are not available.The information indicated that the procedure had been completed with the complaint device detached when angiography was taken and the physician noticed the thrombus in the a2 segment.Information related to what the physician thought may have caused the thrombus could not be obtained.E.1: initial reporter phone: (b)(6).This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00090, 3008114965-2023-00091, and 3008114965-2023-00092.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.

• Brand Name: GALAXY G3 XSFT 4MM X 8CM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 16368903
• Report Number: 3008114965-2023-00090
• Device Sequence Number: 7390782
• Product Code: KRD
• UDI-Device Identifier: 10886704077732
• UDI-Public: 10886704077732
• 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,Followup
• Report Date (Section B): 03/13/2023

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: 11/30/2024
• Device Model Number: GLX120408
• Device Catalogue Number: GLX120408
• Device Lot Number: 30701280
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• 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: 8F OPTIMO GUIDING CATHETER (TOKAI MEDICAL).; HEADWAY® 17 MICROCATHETER (MICROVENTION).; MICROCATHETER.; PULSERIDER T, 3MM, 10MM ARCH.; SOFIA ¿ 5F DISTAL ACCESS CATHETER (MICROVENTION).; SYNCHRO SELECT¿ 14 GUIDEWIRE (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown