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

Model Number	FREDX4023-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post placement of a stent in the clinoid segment, the patient developed a right ica stroke.The proximal end of the stent was post processed with 14wire and microcatheter.The device appeared open and opposed to the vessel wall.The patient woke up and then progressively developed right ica stroke syndrome.Cta/p was negative, mri was negative, and angio was negative.Eventually the patient came back to baseline.
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 is implanted and was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies stroke or tia (transient ischemic attack as a potential complication associated with use of the device.
Additional Manufacturer Narrative
Additional information was received via email stating that the patient is "fine" and that no intervention was undertaken to address the stroke.Normal dapt protocol had been followed pre and post procedure.The vessel size was 3.27 distal, 3.78 proximal.The stent diameter versus the nominal vessel diameter was reported as 4.0 x 23 / 17 used.Angio/images and procedure notes are not available.

• Brand Name: FRED X27
• Common Device Name: 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: 14493365
• Report Number: 2032493-2022-00221
• Device Sequence Number: 6150806
• Product Code: OUT
• UDI-Device Identifier: 00842429114360
• UDI-Public: (01)00842429114360(11)211129(17)241031(10)0000127745
• 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: 2022
• 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): 05/12/2022

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: 10/31/2024
• Device Model Number: FREDX4023-PMA
• Device Catalogue Number: FREDX4023
• Device Lot Number: 0000127745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female