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

Model Number	FREDX5522-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
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 not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The alleged product issue could not be confirmed.If additional information is received at a later date, a supplemental mdr will be submitted.
Event or Problem Description
As reported through the clinical study fred x pas: event #: 4 event description: patient underwent 12-month angiogram that showed stable but unresolved aneurysm.Additional information: the subject went for an attempted retreatment on (b)(6) 2025 with a pipeline device.However, retreatment was unsuccessful due to "there is significant difficulty advancing the microwire and catheter through the [(b)(6)] stent due to severe ica tortuosity and possible irregularities within the stent.On (b)(6) 2025, after attempted and failed retreatment procedure, patient appears to be doing well after her procedure yesterday.No new focal deficit.Subject: (b)(6) additional information: event term: 12-month angiogram shows unresolved aneurysm.Event start date: (b)(6) 2024.Date site was made aware of the event: 16-jul-2024.Reported to irb? yes.Date reported to irb: 12-may-2025.Severity: mild.Was this a serious ae? yes.Date ae was determined to be an sae: (b)(6) 2025.Intervention: (b)(6).Mrs: nihss: not done: (b)(6).Was the ae caused by or associated with a technical event? no.Relationship to study device: possible.Relationship to index endovascular procedure: possible.Relationship to use of ancillary device: not related.Relationship to study disease: probable.Relationship to concomitant disease: possible.Ae outcome: ongoing.Additional information: possible, probable or causal relation to study device or index procedure.
Additional Manufacturer Narrative
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.
Event or Problem Description
Please see h6 & h11.

• 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: 22156507
• Report Number: 2032493-2025-90236
• Device Sequence Number: 8683613
• Product Code: OUT
• UDI-Device Identifier: 00842429114483
• UDI-Public: (01)00842429114483(11)220414(17)250331(10)0000179695
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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 Expiration Date: 03/21/2025
• Device Model Number: FREDX5522-PMA
• Device Lot Number: 0000179695
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2022
• 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: PIPELINE, MEDTRONIC DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown