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

Model Number	FREDX4520-PMA
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.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.
Event or Problem Description
As reported: device opened distally but as we came to deploy proximally it did not open like we had expected, we attempted to gain access through lumen of device with a wire but could not, we used a snare to retrieve the device and placed a web device.Good patient outcome.Aneurysm treated and discharged following day.
Additional Manufacturer Narrative
The investigation found the stent returned fully deployed with a bent proximal flare, which may have contributed to the alleged expansion issue at the proximal end.The microcatheter was returned flattened at 4cm from the distal tip, which may have caused or contributed to the bent proximal stent flare.However, the stent was able to advance through an undamaged in-house microcatheter and fully open upon deployment during the investigation.The physical evaluation of the device could not identify the conditions or circumstances that led to the stent damage, but the damage is consistent with the device experiencing forces exceeding the stent's yield strength.
Event or Problem Description
No new information received.

• Brand Name: STENT
• 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: 23035000
• Report Number: 2032493-2025-90475
• Device Sequence Number: 9217048
• Product Code: OUT
• UDI-Device Identifier: 00842429114407
• UDI-Public: (01)00842429114407(11)240827(17)270731(10)0000681075
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 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): 10/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FREDX4520-PMA
• Device Lot Number: 0000681075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2025
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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 Sex: Female