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

Model Number	FREDX5015-PMA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Ischemia Stroke (4418); Thrombosis/Thrombus (4440); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the flow diverter stent was used to treat a previously treated ruptured posterior communicating artery (pcom) aneurysm.There was a remnant from the use of an intraluminal flow disruption web device in this ruptured pcom.The aneurysm location was at distal ica.Distal measurement of the ica was 4.4mm and proximal landing zone to the aneurysm measured 3.8mm.The size of stent chosen was a 5x15/9.Proper prep of the stent was completed before advancing into the microcatheter.The device opened and deployed nicely with good apposition to the vessel wall.Reportedly, about 3 hours later, the physician reported that the patient had experienced stroke symptoms and could not move half of their body.The patient was taken back to the angio suite for imaging where it was discovered that the stent had migrated into the m1 segment and had clot formation inside.The patient was given integralin and has improved.Reportedly, there was spasm earlier in the procedure.Verapamil was given about 30-45 minutes before stent was deployed.Currently the patient is doing a little bit better, but still had a stroke and is weak on the left side.The stent was oversized and was opposed against the wall of the vessel when implanted.
Additional Manufacturer Narrative
The device was implanted in the patient and is not available for return.Two fluoroscopy images were provided and the investigation is ongoing.Upon completion of the investigation, a supplemental report will be submitted.
Additional Manufacturer Narrative
Investigation conclusion: two radiographic images were provided for review.They show the fred device in the distal right m1 mca with a large filling defect observed in the middle 2/3 of the stent, which is consistent with the alleged product issue.However, the provided images do not explain why the fred migrated or why the clot formed.As reported, the device opened and deployed nicely with good apposition to the vessel wall.Without the return and physical evaluation of the device, the investigation cannot further examine if a condition existed that would have contributed to the reported event.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.

• 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: 23898338
• Report Number: 2032493-2025-90743
• Device Sequence Number: 5092742
• Product Code: OUT
• UDI-Device Identifier: 00842429114445
• UDI-Public: 00842429114445
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 02/04/2026

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: FREDX5015-PMA
• Device Lot Number: 0000553792
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2024
• 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: HEADWAY 27 MICROCATHETER (MICROVENTION).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female