MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21; FLOW DIVERTER

Model Number	FRED2513-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Thrombosis/Thrombus (4440)
Date of Event	08/13/2021
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 remains implanted in the patient and not available for analysis; therefore, the alleged product issue cannot be verified.The instructions for use (ifu) identifies stent thrombosis and stenosis of stented segment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during unspecified procedure, the fred flow diverter stent was positioned and deployed without issue.Immediate cta run looked good, and the vessel looked patent.Subsequent delayed runs showed progressive slower flow with eventual zero patency of vessel and intra-arterial integrelin was administered.Reportedly, the anatomy was challenging with some tortuosity to overcome and some vasospasm was noted and treated during the procedure.Post procedure the patient was stable with slight left side weakness.
Additional Manufacturer Narrative
Additional information received indicating procedure was for treating an acomm aneurysm.No additional intervention performed.Patient was stable.

• Brand Name: FRED 21
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12455239
• Report Number: 2032493-2021-00374
• Device Sequence Number: 14331862
• Product Code: OUT
• UDI-Device Identifier: 00842429106587
• UDI-Public: (01)00842429106587(11)200929(17)230831(10)20092957N
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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: 08/31/2023
• Device Model Number: FRED2513-PMA
• Device Lot Number: 20092957N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/08/2021
• 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