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

Model Number	FRED4026-PMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
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,.
Event or Problem Description
It was reported that treatment was performed for a left ophthalmic internal carotid artery (ica) aneurysm.There was significant vessel diameter discrepancy and vessel tortuosity throughout the petrous and cavernous ica.The fred was deployed around the carotid siphon.The distal and middle sections of the device opened well; however, the proximal end did not open after deployment.Attempts to open the proximal end of the fred with the delivery wire, the microcatheter, and the guide catheter were unsuccessful.During the attempt to retrieve the stent with a gooseneck snare, the proximal finished ends were pushed forward into the open section of the fred.Subsequent angiographic images demonstrated a patent fred and robust flow through the device.There was no evidence of thrombus.The device was left implanted at the intended treatment site.There was no reported patient injury.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 9941824
• Report Number: 2032493-2020-00095
• Device Sequence Number: 13972343
• Product Code: OUT
• UDI-Device Identifier: 00842429106747
• UDI-Public: (01)00842429106747(11)190306(17)220228(10)19030653QM
• 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): 03/09/2020

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: 02/28/2022
• Device Model Number: FRED4026-PMA
• Device Lot Number: 19030653QM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/08/2020
• 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
• Patient Age: 70 YR