MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 3CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM915030
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The event was reported via the sterling study.A 79-year-old female patient underwent a stent-assisted coil embolization of an unruptured aneurysm on (b)(6) 2021.Coil embolization was performed.A 2.00mm x 4.00cm galaxy g3 mini (glm920040 / 30392736) was used but it was not implanted due to coil migration.The embolization continued with the implantation of a 2.50mm x 4.50cm galaxy g3 mini (glm925045 / 30393182).When a 1.50mm x 3.00cm galaxy g3 mini (glm915030 / 30383045) was chosen, the coil was also not implanted due to migration.This coil was followed by a 1.00mm x 3.00cm galaxy g3 mini (glm910030 / 30466099) which was also not used because the coil migrated.The procedure continued with the implantation of stryker coils in the following order: two (2) 1mm x 3cm target 360 nano coils, two (2) 1mm x 2cm target 360 nano coils, and a and a 1mm x 3cm target 360 nano coil.The reported coil migration issue did not result in adverse event or patient complication.
Additional Manufacturer Narrative
(b)(4).The patient date of birth was not provided.Procode is krd/hcg.The initial reporter phone and email address are not available / reported.[conclusion]: the event was reported via the sterling study.A 79-year-old female patient underwent a stent-assisted coil embolization of an unruptured aneurysm on (b)(6) 2021.Coil embolization was performed.A 2.00mm x 4.00cm galaxy g3 mini (glm920040 / 30392736) was used but it was not implanted due to coil migration.The embolization continued with the implantation of a 2.50mm x 4.50cm galaxy g3 mini (glm925045 / 30393182).When a 1.50mm x 3.00cm galaxy g3 mini (glm915030 / 30383045) was chosen, the coil was also not implanted due to migration.This coil was followed by a 1.00mm x 3.00cm galaxy g3 mini (glm910030 / 30466099) which was also not used because the coil migrated.The procedure continued with the implantation of stryker coils in the following order: two (2) 1mm x 3cm target 360 nano coils, two (2) 1mm x 2cm target 360 nano coils, and a and a 1mm x 3cm target 360 nano coil.The reported coil migration issue did not result in adverse event or patient complication.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30383045) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances 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 migration is a known potential complication associated with coil embolization procedures.Assignment of root cause for the coil migration remains speculative and inconclusive.However, there are clinical and procedural factors including aneurysm/vessel characteristics, device interaction, device selection, anatomical challenges, and operator technique that may have contributed to the reported event rather than the design or manufacture of the device.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Coil migration is considered a reportable "malfunction" as it could result in non-target site embolization, ischemia, or infarct, and may require additional intervention.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: 3008114965-2022-00153, and 3008114965-2022-00155.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 is to include the additional/modified event information received on 04-mar-2024, that changed the reportability of the event as related to this product reported in this medwatch report.[additional / modified information]: on 04-mar-2024, modified information was received.Per the information, the device deficiency of coil migration associated with this coil, a 1.50mm x 3.00cm galaxy g3 mini (glm915030 / 30383045) was inactivated.Via email and phone discussion with the sterling clinical study team, the following clarification was received: the placement of the pulserider device failed and the strategy was changed to stent-assisted coil embolization.After placing a 3mm x 15mm neuroform atlas® stent (stryker) from the left a2 segment of the anterior communicating artery, intracranial coil embolization was started.The 2.50mm x 4.50cm galaxy g3 mini (glm925045 / 30393182) was placed as the first coil.Then the second coil, 2.00mm x 4.00cm galaxy g3 mini (glm920040 / 30392736) was placed, but it pushed the first coil and one loop of the first coil became protruded outside of the aneurysm.As a result, the second coil was retrieved and another 3mm x 15mm neuroform atlas® stent was then deployed from the right of the a2 segment as a y-stent; this pressed the protruded loop of the first coil to the vessel wall.The information indicated that the 1.50mm x 3.00cm galaxy g3 mini (glm915030 / 30383045) and 1.00mm x 3.00cm galaxy g3 mini (glm910030 / 30466099) were retrieved because they did not fit inside of the aneurysm; the aneurysm was full.Additional information received 15-mar-2024 from the sterling clinical study team.Per the information, the first implanted stent did not adequately cover the aneurysm.As a result, the 2.50mm x 4.50cm galaxy g3 mini (glm925045 / 30393182) deviated and a loop became protruded outside of the aneurysm.The second stent was used to hold down the deviated loop, which was not adequately covered by the first stent, but remained in place until the last coil.The 1.50mm x 3.00cm galaxy g3 mini (glm915030 / 30383045) and 1.00mm x 3.00cm galaxy g3 mini (glm910030 / 30466099) were retrieved because they deviated outside the aneurysm and could not be implanted.Subsequently, competitor coils were implanted to embolize the aneurysm.A balloon catheter was prepared for rupture but was not used in the vessel.The reportability of the file was also reassessed.Based on the information provided, the event no longer meets no longer meets usfda medical device reporting criteria.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00153, 3008114965-2022-00154, and 3008114965-2022-00155.

• Brand Name: GALAXY G3 MINI 1.5MM X 3CM
• 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: 13759660
• Report Number: 3008114965-2022-00154
• Device Sequence Number: 5780181
• Product Code: KRD
• UDI-Device Identifier: 10886704080145
• UDI-Public: 10886704080145
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

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: 03/31/2023
• Device Model Number: GLM915030
• Device Catalogue Number: GLM915030
• Device Lot Number: 30383045
• 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: 02/24/2022
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2020
• 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: EXCELSIOR® SL-10®45° MICROCATHETER (STRYKER); MICROCATHETER
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian