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

Model Number	FREDX3019-PMA
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
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 not returned 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 mdr report.
Event or Problem Description
As reported, mca aneurysm embolization.Device was deployed successfully through headway21.It appeared partially open at the proximal end once we unsheathed past the deployment zone of the delivery push wire.We could not discern visually but at least one of the struts did not release fully from the deployment wire/ retainment shoulders of the deployment area.And when pulling the system back, to free it from the device proximal zone, it pulled the entire stent back to a poor position.We then were forced to retrieve the device with a loop snare which we did using the headway 21 and sofia 5fr 125.It was successfully retrieved and the patient is in normal baseline condition.We did not treat the patient with any other device.Additional information indicated, it was decided to not treat based on the consideration to vessel intima injury and subsequent repercussion from that.

• 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: 24099918
• Report Number: 2032493-2026-00023
• Device Sequence Number: 10296328
• Product Code: OUT
• UDI-Device Identifier: 00842429114261
• UDI-Public: (01)00842429114261
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• 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): 01/16/2026

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: FREDX3019-PMA
• Device Lot Number: 0000637989
• Was Device Available for Evaluation?: Yes
• 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: 01/08/2026
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male