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

Model Number	FRED4518-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/06/2020
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 implanted in the patient and not returned to the manufacturer for evaluation.Intraprocedural or post-procedural images were not provided for review; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies stent thrombosis as a potential complication associated with use of the device.
Event or Problem Description
It was reported that the fred was successfully implanted as treatment for a left internal carotid artery (ica) aneurysm.Post-procedure, thrombus developed inside the stent.Aspiration thrombectomy was performed and integrilin was administered, which completely resolved the thrombus.There was no sequela.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10807086
• Report Number: 2032493-2020-00318
• Device Sequence Number: 11637991
• Product Code: OUT
• UDI-Device Identifier: 00842429106785
• UDI-Public: (01)00842429106785(11)200624(17)230531(10)200624598
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2020

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?: No
• Operator of Device: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: FRED4518-PMA
• Device Lot Number: 200624598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/08/2020
• 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