MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; FLOW DIVERTER

Model Number	FRED4518-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	03/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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.Intraprocedural or post-procedural images were not provided for review; therefore, the reported event cannot be confirmed.The instructions for use identifies thrombosis and visual impairment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during implantation of the fred to treat a left ophthalmic artery aneurysm, a filling defect was noted at the proximal end of the stent and the ophthalmic artery closed down.Integrilin was given, which restored flow.Six months post-procedure, a filling defect was still present at the proximal end of the stent and the ophthalmic artery was closed.The patient was reported to have blurred vision in the left eye.There was no reported device malfunction.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10844823
• Report Number: 2032493-2020-00332
• Device Sequence Number: 3732733
• Product Code: OUT
• UDI-Device Identifier: 00842429106785
• UDI-Public: (01)00842429106785(11)190422(17)220331(10)19042253QM
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: FRED4518-PMA
• Device Lot Number: 19042253QM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability