MAUDE Adverse Event Report: MICROVENTION, INC. AZUR VACULAR PLUG; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-180500
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the actual part/lot number combination could not be performed as the lot number was unknown.The actual device was discarded by the user facility and was not available for return to the manufacturer for analysis.The alleged product issue could not be confirmed.Supplemental imaging was not provided for review.The event as described could not be confirmed.If more information is received at a later date, and analysis will be performed and a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient was submitted to a pre evar inferior mesenteric artery embolization.The plug selected for treatment migrated.A snare was used to remove it.The ima was then embolized with coils.The procedure was successful.

• Brand Name: AZUR VACULAR PLUG
• 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: 24174897
• Report Number: 2032493-2026-00036
• Device Sequence Number: 8197570
• Product Code: KRD
• UDI-Device Identifier: 00842429101612
• UDI-Public: 00842429101612
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45-180500
• Device Catalogue Number: 45-180500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 01/06/2026
• Initial Report FDA Received Date: 01/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown