MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 3.5MM X 9CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY123509
Medical Device Problem Codes	Stretched (1601); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
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.Section d.2b: procode is krd/hcg.Section e.1: the name, phone and email address of the initial reporter are not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30704827) 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.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 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.
Event or Problem Description
The healthcare professional reported that during a stent-assisted coil embolization procedure targeting an aneurysm on the anterior communicating artery (acomm), after implantation of the stent, the coil embolization was conducted via trans-cell method.The complaint coil, a 3.5mm x 9cm galaxy g3 (gly123509 / 30704827) was used as the fifth coil.It was reported that the complaint coil did not wind at the target lesion and had to be re-sheathed and rewound several times.¿at that time, popping was felt in hand and the coil was unraveled.¿ the coil was still in the concomitant phenom¿ microcatheter (medtronic) and was retrieved with the microcatheter.The procedure was successfully completed with another microcatheter and coil.It was not known if a continuous flush was maintained.There was no report of any negative patient impact.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 07-may-2023.[additional information]: on 07-may-2023, additional information was received.The information indicated that a continuous flush was maintained through the microcatheter.The coil had been repositioned several times (the number of times was not specified in the information received).There was no resistance between the guidewire and microcatheter when the target site was being accessed.There were no kinks on the microcatheter that may have contributed to the reported issue.The reported issue occurred during the repositioning in the aneurysm.There was no blood flow restriction / reduction as a result of the reported issue.There was no clinically significant delay in the procedure as a result of the reported issue.Section e.1: initial reporter phone: 06-6771-6051.Updated sections: b.4, e.1, e.3, g.3, g.6, h.2, and h.10.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 30-may-2023.[additional information]: on 30-may-2023, additional information was received.The information indicated that the patient is a female and the target aneurysm was an anterior communicating artery (acom) aneurysm about 5mm in diameter and of an ¿elliptic type.¿ the stent implanted was a neuroform atlas® stent system (stryker).The information indicated that the microcatheter was not repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the microcatheter.Detailed information regarding possible coil entanglement with previously placed coil could not be obtained, however, ¿there should be some friction with the previously placed coils, because the [complaint] coil inserted was the 5th coil.¿ there was no blood flow restriction / reduction as a result of the reported issue.The replacement coil was not a cerenovus coil; it was a competitor coil.The microcatheter replaced was another phenom microcatheter.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 3.5MM X 9CM
• 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): CERENOVUS, INC.; 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 16879613
• Report Number: 3008114965-2023-00251
• Device Sequence Number: 17956007
• Product Code: KRD
• UDI-Device Identifier: 10886704077442
• UDI-Public: 10886704077442
• 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,Followup
• Report Date (Section B): 05/31/2023

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: 11/30/2024
• Device Model Number: GLY123509
• Device Catalogue Number: GLY123509
• Device Lot Number: 30704827
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 05/07/2023; 05/31/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 05/08/2023; 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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: ENPOWER CONTROL CABLE.; NEUROFORM ATLAS® STENT SYSTEM (STRYKER).; PHENOM¿ MICROCATHETER (MEDTRONIC).
• Patient Sex: Female