MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SIEGE¿ VASCULAR PLUG; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	SVP4-0.021
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
Event or Problem Description
The account alleges two siege devices were successfully placed in an 8 month old patient.During the procedure the collateral was sized many times and determined to be 3.7mm.After review a 6.5mm siege plug was used alongside a correctly sized terumo progreat.The device was prepped and placed successfully around a curve.Once the device was in a good position it was deployed, good view of the radiopaque markers and lobes was visible.Flow was still noticeable at the two minute mark.After a total of 15 minutes the flow became noticeably sluggish.The second collateral was 2.2mm and a 4.5mm siege plug was used.The device was prepped and placed successfully.After 20 minutes there was no change in the flow through the collateral.The clinician decided to keep the device in and will check on it after some time.No additional patient consequence to report.

• Brand Name: SIEGE¿ VASCULAR PLUG
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22717356
• Report Number: 1721504-2025-00237
• Device Sequence Number: 13053789
• Product Code: KRD
• UDI-Device Identifier: 00884450815915
• UDI-Public: 00884450815915
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K240261
• 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
• Report Date (Section B): 08/05/2025

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 Catalogue Number: SVP4-0.021
• Device Lot Number: 204657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2024
• 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