MAUDE Adverse Event Report: MICROVENTION, INC. FRED X21; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FREDX4520-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported through the fred x pas clinical study, event #4, asymptomatic ophthalmic artery occlusion.Event start date : (b)(6) 2024.Severity : mild.Was this a serious ae? : no.Was the ae caused by or associated with a technical event? : no.Relationship to study device: probable.Relationship to index endovascular procedure: probable.Relationship to use of ancillary device: not related.Relationship to study disease: possible.Relationship to concomitant disease: possible.Ae outcome: ongoing.Additional information indicated: treatment site: right carotid ophthalmic aneurysm index procedure performed: (b)(6) 2024.During the study procedure, two fredx devices were used to cover the aneurysm neck.The participant presented on (b)(6) 2024 for a regular scheduled 6m fu imaging.It was during this fu imaging that the asymptomatic occlusion was first seen on (b)(6) 2024.No action/ intervention taken as participant is asymptomatic.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 implanted in the patient and is not available for return to the manufacturer for analysis.Therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.The instructions for use (ifu) identifies vessel occlusion as potential complications associated with use of the device.

• Brand Name: FRED X21
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• 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: 24533337
• Report Number: 2032493-2026-00155
• Device Sequence Number: 8895416
• Product Code: OUT
• UDI-Device Identifier: 00842429114407
• UDI-Public: (01)00842429114407
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: FREDX4520-PMA
• Device Lot Number: 0000543055
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FREDX4515.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 71 KG