MAUDE Adverse Event Report: MICROVENTION, INC. FRED X27; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FREDX4032-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	10/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The alleged product issue could not be confirmed.If additional information is received at a later date, a supplemental mdr will be submitted.
Event or Problem Description
As reported, in conversation, physician shared that a patient he treated successfully with fredx, came to the er 6 days after the stent implant with a bad headache and stroke-like symptoms.The physician stated that imaging showed that there was an occlusion in the rica where the stent was implanted.The imaging showed collateral filling from the lica to the rica cerebral arteries through the anterior communicating artery.Physician states that patient was prepped with dapt and that day of p2y12 was 134 and aspirin was being taken by patient.The procedure was to treat a cavernous aneurysm that incorporated the rica.The physician states that he used a jailing technique with a coiling microcatheter and deployed the stent and then coiled and then removed microcatheter.Patient status is discharged with an nih of 3 and discharged to rehab after 10 days of icu stay.The extended stay was to help with blood pressure management.
Additional Manufacturer Narrative
Corrections: adverse event or product problem.B2 selected: add, hospitalization, initial or prolonged.Adverse event problem, health effect.H6, health effect, impact code, add 4607, hospitalization, initial or prolonged.Investigation conclusion.The reported event is non-verifiable.The physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported 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.
Event or Problem Description
Although requested, no additional information has been provided.Please see h6 and h11.

• Brand Name: FRED X27
• 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: 23712884
• Report Number: 2032493-2025-90685
• Device Sequence Number: 16052791
• Product Code: OUT
• UDI-Device Identifier: 00842429114377
• UDI-Public: 00842429114377
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 12/26/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: FREDX4032-PMA
• Device Lot Number: 0000469600
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2023
• 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 COIL.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Unknown