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

Model Number	FREDX3019-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was implanted in the patient and remains implanted.Investigation conclusion: the physical device was not available for evaluation to investigate if a condition existed that would have contributed to 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
It was reported that the flow diverter stent device was being used to treat a patient with left middle cerebral artery aneurysm.A web embolization device was first implanted, then the flow diverter stent was implanted with minimal difficulty.The physician did have to reposition as the device was too distal.After repositioning the device was deployed across the aneurysm neck and deployed just proximal to the aneurysm with a push of the last segment of device for complete deployment.Post angio run showed complete opening of the device and filling of distal vessels.After the procedure, the patient woke up moving all extremities but was sleepy.Approximately one hour later, the physician reported there was clot in the device and the patient started displaying stroke like symptoms.The patient was brought back and the physician attempted mechanical thrombectomy, but the aspiration catheter got caught on proximal device and pushed it into the aneurysm.The physician gave various medications (tpa, cangrelor, and integrilin) that eventually dissolved the clot.The patient was left intubated and under anesthetics.Upon follow-up, the physician reported that the patient is doing a little better every day.

• 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: 21893625
• Report Number: 2032493-2025-90100
• Device Sequence Number: 8174756
• Product Code: OUT
• UDI-Device Identifier: 00842429114261
• UDI-Public: (01)00842429114261(11)240725(17)270630(10)0000649123
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/23/2025

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: FREDX3019-PMA
• Device Lot Number: 0000649123
• 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: 04/09/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• 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: WEB EMBOLIZATION DEVICE (MICROVENTION)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female