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

Model Number	FRED4012-PMA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	07/23/2020
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 evaluation.The root cause of the complaint cannot be determined.The instructions for use (ifu) identifies vessel stenosis or thrombosis as a potential complication associated with use of the device.
Event or Problem Description
It was reported that the fred was deployed without incident in the internal carotid artery (ica).Post-deployment, thrombus developed on the proximal portion of the fred and the ica became occluded.Integrilin was administered intra-arterially and the ica opened up.It appeared that the inner stent of the fred was separated from the outer stent.The stent was opened and the patient woke up neurologically intact.There was no reported sequela.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10439817
• Report Number: 2032493-2020-00223
• Device Sequence Number: 2963470
• Product Code: OUT
• UDI-Device Identifier: 00842429106723
• UDI-Public: (01)00842429106723(11)200213(17)230131(10)200213569
• 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): 07/23/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/21/2020
• 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