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

Model Number	FRED4012-PMA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/24/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
A search for non-conformance 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 implanted in the patient and was not returned to the manufacturer for analysis.Procedural images were not provided for review; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies device migration, vessel occlusion, vessel stenosis or thrombosis, and neurological deficits including stroke and/or death as potential complications associated with use of the device.
Event or Problem Description
It was reported that treatment was performed for an internal carotid artery (ica) aneurysm.After the fred was implanted in the ica, the fred and the ica became totally occluded with clot.There was no flow to the patient's left cerebral hemisphere.The fred migrated and the aneurysm was left open to blood flow.The next day, the aneurysm was embolized with coils.The patient died sometime later; however, the date and cause of death is unknown.The relationship of the fred to the death is unknown.
Additional Manufacturer Narrative
Patient status update was provided on (b)(6) 2020, which indicated the physician stated the patient died from a stroke.The date of the patient's death is unknown.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10731592
• Report Number: 2032493-2020-00309
• Device Sequence Number: 1679530
• Product Code: OUT
• UDI-Device Identifier: 00842429106723
• UDI-Public: (01)00842429106723(11)200213(17)230131(10)200213569
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2023
• Device Model Number: FRED4012-PMA
• Device Lot Number: 200213569
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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: Death; Life Threatening; Required Intervention