MAUDE Adverse Event Report: CERENOVUS, INC. GALAXY G3 MINI 1.5MM X 2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM915020
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section a1.1.Patient identifier: (b)(6).Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00494.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported via the sterling study, a 66-year-old female, underwent coil embolization of a ruptured left pericallosal artery aneurysm on (b)(6) 2022.The dimension of the aneurysm was as follows: height 4mm, dome 3.7mm, maximum aneurysm diameter 4.7mm, neck size 1.4mm, and dome-to-neck ratio of 2.6mm.The parent vessel diameter was 1.8mm.Coil embolization was performed successfully with three (3) cerenovus coils and in the opinion of the investigator, treatment of the target aneurysm was considered complete, and the study coils were successfully implanted at the target site.Two additional cerenovus coils, a galaxy g3 xsft 2mm x 2cm (glx120202/ 30566874) and a galaxy g3 mini 1.5mm x 2cm (glm915020/ 30768280) were attempted to be used during the embolization procedure but were not implanted as per information received ¿the coils didn't penetrate properly the aneurysm¿ i.E., there was coil positioning difficulty with coil herniation.There were no reported intraoperative complications.The patient was discharged home on (b)(6) 2022.
Additional Manufacturer Narrative
Product complaint # (b)(6), updated sections on this medwatch: b4, g3, g6, h2, h6 and h10.Complaint conclusion: as reported via the sterling study, a 66-year-old female, underwent coil embolization of a ruptured left pericallosal artery aneurysm on (b)(6) 2022.The dimension of the aneurysm was as follows: height 4mm, dome 3.7mm, maximum aneurysm diameter 4.7mm, neck size 1.4mm, and dome-to-neck ratio of 2.6mm.The parent vessel diameter was 1.8mm.Coil embolization was performed successfully with three (3) cerenovus coils and in the opinion of the investigator, treatment of the target aneurysm was considered complete, and the study coils were successfully implanted at the target site.Two additional cerenovus coils, a galaxy g3 xsft 2mm x 2cm (glx120202/ 30566874) and a galaxy g3 mini 1.5mm x 2cm (glm915020/ 30768280) were attempted to be used during the embolization procedure but were not implanted as per information received ¿the coils didn't penetrate properly the aneurysm¿ i.E., there was coil positioning difficulty with coil herniation.There were no reported intraoperative complications.The patient was discharged home on (b)(6) 2022.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30768280 number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.The ifu instructs on proper positioning of the microcoil system.The ifu also warns: ¿if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system¿.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 MINI 1.5MM X 2CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CERENOVUS, INC.; 6303 waterford district drive; suites 215 & 315; miami FL 33126
• Manufacturer (Section G): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17308361
• Report Number: 3008114965-2023-00495
• Device Sequence Number: 7185017
• Product Code: KRD
• UDI-Device Identifier: 10886704080138
• UDI-Public: 10886704080138
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 02/28/2025
• Device Model Number: GLM915020
• Device Catalogue Number: GLM915020
• Device Lot Number: 30768280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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 XSFT 2MM X 2CM
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White