MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 3MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM930060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.[conclusion]: the healthcare professional reported an adverse event that occurred during an endovascular coil embolization procedure targeting an anterior communicating artery (acom) aneurysm.A hydro coil (competitor product) was implanted as the first coil.Two (2) 3.00mm x 6.00cm galaxy g3 mini coils (glm930060 / lot# unknown) were used.It was reported that ¿the complaint coils moved as if ruptured the aneurysm, but the complaint coils were implanted as scheduled.¿ a mini coil (unspecified brand) was inserted as the third coil, but it was confirmed that the coils pierced the aneurysm.As a result, coil embolization was completed with other competitor coils.It was reported that a continuous flush was maintained.The reported event was considered non-serious (moderate / minimal).No other details were provided.Based on complaint information, the device remains implanted and is thus not available for evaluation.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As a result, the investigation will be closed.Aneurysm rupture is a known potential adverse event associated with coil embolization procedures.However, the device performed as intended, and no new patient consequences have occurred related to the use of the device.There was no report of a device malfunction.Since the aneurysm rupture required endovascular embolization and the relationship of the cerenovus coils implanted at the target aneurysm to the reported aneurysm rupture cannot be excluded at this time, the event meets mdr reporting criteria with the classification of ¿serious injury.¿ based on the device history record review, there is no indication that the event is related to the device manufacturing process.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 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00522 and 3008114965-2022-00523.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.
Event or Problem Description
The healthcare professional reported an adverse event that occurred during an endovascular coil embolization procedure targeting an anterior communicating artery (acom) aneurysm.A hydro coil (competitor product) was implanted as the first coil.Two (2) 3.00mm x 6.00cm galaxy g3 mini coils (glm930060 / lot# unknown) were used.It was reported that ¿the complaint coils moved as if ruptured the aneurysm, but the complaint coils were implanted as scheduled.¿ a mini coil (unspecified brand) was inserted as the third coil, but it was confirmed that the coils pierced the aneurysm.As a result, coil embolization was completed with other competitor coils.It was reported that a continuous flush was maintained.The reported event was considered non-serious (moderate / minimal).No other details were provided.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 19-aug-2022.[additional information]: on 19-aug-2022, the cerenovus sales rep provided the following additional information: the information indicated that ¿the coil deviated, but there was no bleeding and no additional medical treatment.¿ the patient recovered and was discharged from the hospital.There is no negative health impact for the patient.There are no plans for future additional medical treatment.The physician has commented that ¿the microcatheter may have been inserted too far into the back.¿ no further information is available.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00522 and 3008114965-2022-00523.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 26-aug-2022.[additional information]: on 26-aug-2022, initial reporter information was received.All other information related to the device and the procedure-related details were not available.E.1: initial reporter phone: (b)(6).This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00522 and 3008114965-2022-00523.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 MINI 3MM 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
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15227797
• Report Number: 3008114965-2022-00522
• Device Sequence Number: 12154068
• Product Code: KRD
• UDI-Device Identifier: 10886704080336
• UDI-Public: 10886704080336
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 08/26/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: GLM930060
• Device Catalogue Number: GLM930060
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 08/26/2022; 08/26/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 08/25/2022; 08/26/2022
• 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: GALAXY G3 MINI 3MM X 6CM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown