MAUDE Adverse Event Report: MicroVention, Inc. FRED X27; Intracranial Aneurysm Flow Diverter

Model Number	FREDX4520-PMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury

• Brand Name: FRED X27
• Common Device Name: Intracranial Aneurysm Flow Diverter
• Manufacturer (Section D): MicroVention, Inc.; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MicroVention, Inc.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; +1(714)247-8000
• MDR Report Key: 50624980
• Report Number: 2032493-2026-08214
• Device Sequence Number: 21507215
• Product Code: OUT
• UDI-Device Identifier: 00842429114407
• UDI-Public: (01)00842429114407(11)240723(17)270630(10)0000654928
• 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
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: FREDX4520-PMA
• Device Lot Number: 0000654928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/05/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown