MAUDE Adverse Event Report: MICROVENTION, INC. VIA MICROCATHETER; CATHETER, PERCUTANEOUS

Model Number	VIA-33-133-01-AL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded at the user facility and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The event as described could not be confirmed.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.
Event or Problem Description
It was reported that during a middle cerebral artery aneurysm procedure, the physicians were about to deploy the web to treat the aneurysm and did a run and noticed that there was a bleed.They then deployed and detached the web successfully.They then used coils and a stent to finish the case successfully.They are not completely sure as to the cause of the bleed, stating it may have been before the deployment, while they were introducing the micro catheter.The patient was ok at the end of the procedure.Stasis was achieved in the aneurysm.

• Brand Name: VIA MICROCATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 24089602
• Report Number: 2032493-2026-00020
• Device Sequence Number: 21249223
• Product Code: DQY
• UDI-Device Identifier: 00842429118733
• UDI-Public: 00842429118733
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/15/2026

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: VIA-33-133-01-AL
• Device Catalogue Number: VIA-33-133-01
• Device Lot Number: 0001033269
• 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: 12/22/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2025
• 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: UNKNOWN COILS; UNKNOWN STENT; WEB SL
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown