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

Model Number	FREDX3513-PMA
Medical Device Problem Codes	Entrapment of Device (1212); Retraction Problem (1536); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
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 returned to the manufacturer for analysis and the investigation ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
It was reported that this complaint concerns the lead wire of the fredx device associated.Device was implanted without any opening complications.Successfully implanted into the patients ica at the level of the pcom artery.Upon removal of the pusher wire/ delivery system, the lead wire snagged the proximal part of the fredx device.Attempts to pull the wire free only began to stretch and distort the proximal body of the fredx device.The catheter was then advanced to the snagged lead wire and ultimately the wire was freed of its retention.The entire wire and catheter system was removed at no consequence to the fredx device.The stent remained where initially implanted.It did not lose position due to this reported issue.Patient¿s condition is stable and was unaffected by the complaint issue.
Additional Manufacturer Narrative
Investigation conclusion: a single 11-second video was provided for review.It is not labeled as to date or time or what carotid the devices are located in.The non-subtracted fluoroscopy video is centered on the skull base in ap and lateral projections with no contrast.A short fred device is seen in the proximal supraclinoid carotid.It appears well opened.During the video, the pusher wire is being withdrawn and can be seen snagging the proximal ¿feet¿ of the fred device.The delivery microcatheter is then advanced to the distal aspect of the pusher wire, which is located within the proximal aspect of the fred.At that point, the pusher wire can be brought back into the delivery microcatheter.After retrieval of the pusher wire, there has been no disturbance of the fred device.This video confirms the alleged product issue; however, it does not explain why the issue occurred.The investigation of the returned pusher found no damage or other anomaly that would have caused or contributed to the reported complaint.Per the event description the stent was implanted and therefore, the investigation could not determine if a condition existed on the stent that would have caused or contributed to the reported event.
Event or Problem Description
Please see section h11 for device investigation results.

• 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: 22919391
• Report Number: 2032493-2025-90441
• Device Sequence Number: 15925928
• Product Code: OUT
• UDI-Device Identifier: 00842429114292
• UDI-Public: (01)00842429114292(11)240730(17)270630(10)0000664025
• 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
• 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): 10/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FREDX3513-PMA
• Device Lot Number: 0000664025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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 CATHETER.
• Patient Sex: Female