MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 18D-LONGER; DEVICE VASCULAR FOR PROMOTING EMBOLIZATION

Model Number	45-780828-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was stated to be available for return to the manufacturer but it has not yet been returned.The alleged product issue could not be confirmed.If it is received at a later date, an investigation will be performed and a supplemental report will be submitted.The instructions for use identifies premature separation as a potential complication associated with use of the device.
Event or Problem Description
It was reported that the product "came apart during use." there was no reported patient injury or intervention.
Additional Manufacturer Narrative
The device was received for evaluation and the implant was confirmed to be still attached to the pusher.Based on our investigation findings and clarifying information received from the reporter, there was no coil detachment malfunction.The coil was stretched.Therefore, mvi no longer considers this event a reportable malfunction event.Corrected data: b5.
Event or Problem Description
Updated information was received.No intervention was needed.The coil stretched and was removed from the body with no issue.It did not detach.Outcome of patient was fine.

• Brand Name: AZUR CX 18D-LONGER
• Common Device Name: DEVICE VASCULAR FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 22549406
• Report Number: 2032493-2025-90339
• Device Sequence Number: 4022109
• Product Code: KRD
• UDI-Device Identifier: 00810170018336
• UDI-Public: 00810170018336
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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 Model Number: 45-780828-L
• Device Lot Number: 0000553117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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
• Patient Sex: Unknown