MAUDE Adverse Event Report: MICROVENTION, INC. VASCULAR PLUG 18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-180800
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the vascular azur plug was used in a radial approach splenic artery bleed embolization.The vessel measured just over 6mm and the physician decided to place an 8mm azur plug through a microcatheter.The placement went well, but after a few shots, the plug migrated distally.The 8mm plus embolized safely and remained in the patient.The physician then decided to go with a larger 10mm plug and during preparation outside of the body, the 10mm plug unintentionally detached rendering it unusable.The physician then attempted to place multiple embolization coils (x6) but the coils would not advance through entire microcatheter.A new microcatheter was replaced and the case was finished successfully with competitor coils.There was no report of harm to the patient.
Additional Manufacturer Narrative
Investigation conclusion: the physical device was not available for evaluation to investigate if a condition existed that would have contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation further examine the cause of the reported event.This information may be updated if additional information is provided at a later date.

• Brand Name: VASCULAR PLUG 18
• 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: 22822113
• Report Number: 2032493-2025-90409
• Device Sequence Number: 15892793
• Product Code: KRD
• UDI-Device Identifier: 00842429101629
• UDI-Public: (01)00842429101629(11)250313(17)280229(10)0001028984
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: 45-180800
• Device Lot Number: 0001028984
• 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: 07/28/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AZUR CX 18D-LONGER COIL (X6) (MVI); AZUR VASCULAR PLUG - LARGE (MVI); PG PRO MICROCATHETER (TERUMO)
• Patient Age: 19 YR
• Patient Sex: Male