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

Model Number	FRED3516-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Date of Event	05/28/2021
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.Post procedural images were not provided.Therefore, the reported event could not be confirmed.The instructions for use (ifu) identifies thrombus and stroke as potential complications associated with use of the device.
Event or Problem Description
It was reported that a on (b)(6) 2021 a fred stent was successfully implanted to treat a left vertebral artery aneurysm.On (b)(6) 2021, the patient returned to the hospital with stroke like symptoms.The stent had formed thrombus which was removed with an aspiration catheter.The patient was placed on an integrillin drip overnight.
Additional Manufacturer Narrative
Additional media was provided by the customer.From the image, there was no measurement of the narrow section of the artery.The image showed an atherosclerotic diseased vessel which can increase the potential for mal apposition.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12292094
• Report Number: 2032493-2021-00314
• Device Sequence Number: 3636066
• Product Code: OUT
• UDI-Device Identifier: 00842429106679
• UDI-Public: (01)00842429106679(11)200604(17)230531(10)200604524
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 07/09/2021

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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: FRED3516-PMA
• Device Lot Number: 200604524
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/08/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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: Other; Required Intervention