MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 PUSHABLE HYDRO; VASCULAR EMBOLIZATION DEVICE

Model Number	45-280406
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
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 for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts have been made for the device return.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the coil prematurely exited the delivery system before it entered the target lesion.An intervention was performed to remove the coil.The case was successfully completed using another coil.There was no reported harm or injury to the patient.Additional information provided that a mapca procedure was performed at hospital acibadem sistina.
Additional Manufacturer Narrative
No additional incident information was received, however the following fields have been updated: a2, a3, d10, e1, h6.The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
No additional incident information was received, however updated hospital information, physician name and some patient demographics were obtained.
Event or Problem Description
No additional incident information was received; however, the evaluation of the returned device is completed.Please see h6 & h11.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned coil system found the introducer to be kinked/broken at the distal section, and the implant to be kinked and deformed with the overcoil damaged.The implant was returned deployed from the introducer.However, supplemental imaging was not provided for review; without procedure imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the introducer and implant damage, but the damage is consistent with the device experiencing forces exceeding the introducer and implant's yield strength.

• Brand Name: AZUR 18 PUSHABLE HYDRO
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• 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: 24405221
• Report Number: 2032493-2026-00110
• Device Sequence Number: 18198547
• Product Code: KRD
• UDI-Device Identifier: 00810170012181
• UDI-Public: 00810170012181
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130577
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2026

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: 45-280406
• Device Lot Number: 0001099928
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/23/2026; 03/24/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/17/2026; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male