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	Death (1802); Thrombus (2101)
Date of Event	03/12/2020
Type of Reportable Event	Death
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 not returned to the manufacturer for analysis.The root cause cannot be determined.The instructions for use (ifu) identifies thrombosis as a potential complication associated with use of the device.
Event or Problem Description
It was reported that the fred was implanted on (b)(6) 2020 as treatment for an unruptured anterior communicating artery aneurysm.The fred performed as expected and was placed in an optimal position in the vessel.There were no patient or device complications during the procedure.Follow-up angiograms were taken up to 30 minutes post-procedure, and there did not appear to be thrombus in the vessel or within the stent, or evidence of a bleed.On (b)(6) 2020, ct imaging demonstrated thrombus within the stent.The patient was taken to the cath lab and the clot was treated and resolved.It was reported that the next day the patient had a bleed and was taken to the operation room.The following day, the patient expired.The cause of the patient's death is unknown.

• Brand Name: FRED 21
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9950989
• Report Number: 2032493-2020-00097
• Device Sequence Number: 14270750
• Product Code: OUT
• UDI-Device Identifier: 00842429106587
• UDI-Public: (01)00842429106587(11)191028(17)220930(10)19102858JM
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2022
• Device Model Number: FRED2513-PMA
• Device Lot Number: 19102858JM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/10/2020
• 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