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

Model Number	FREDX4520-PMA
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
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 implanted in the patient and is not available for return.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
As reported through fredx pas clinical study, the flow diverter stent was used to treat a patient for right superior hypophyseal aneurysm embolization.Reportedly, at 6-month follow-up imaging on (b)(6) 2024, proximal foreshortening of the stent was reported.Patient outcome indicated as: mrs was 1 at baseline, and 0 at the 1-year follow-up on (b)(6) 2025.Additional information was request but has not been received.
Additional Manufacturer Narrative
Additional information was received indicating no additional treatment/intervention was required as a result of the reported malfunction.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
As reported through fredx pas clinical study: per corelab image read of the 6-month fu imaging performed on (b)(6) 2024, "proximal foreshortening" of the fredx stent was reported.No report of injury to the patient.
Additional Manufacturer Narrative
This supplemental report is submitted to provided additional information received and investigation conclusion.Additional information was received.The hospital confirm the intended lesion was still covered despite the stent shortening.There was no concern about the stent shortening.No issues were noted during index procedure.Investigation conclusion: the physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported 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.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: 22909153
• Report Number: 2032493-2025-90436
• Device Sequence Number: 8851508
• Product Code: OUT
• UDI-Device Identifier: 00842429114469
• UDI-Public: (01)00842429114469(11)221005(17)250930(10)0000266483
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2025

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 Expiration Date: 09/30/2025
• Device Model Number: FREDX4520-PMA
• Device Lot Number: 0000266483
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 09/02/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 08/27/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown