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

Model Number	FRED4508-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was implanted in the patient and not returned to the manufacturer for analysis.Post procedural images were not provided; therefore the reported event could not be confirmed.A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The instructions for use identifies hemiplegia, ischemic stroke and sent thrombosis as potential complications associated with use of the device.
Event or Problem Description
It was reported that a fred stent was implanted in the right internal carotid artery (ica) for retreatment of an aneurysm that was coiled approximately 6 months ago for an acute rupture and had a neck remaining.Post deployment, the patient woke up with left sided weakness.Another angio was performed that identified what appeared to be a clot in the lumen of the fred device.Attempts were made to aspirate the clot and remove the fred device using a snare device but was unsuccessful.Reportedly, the patient suffered large hypoxic injury of grey matter.
Additional Manufacturer Narrative
Additional information received via email indicated that the patient's impairment was permanent and they were on a ventilator.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11932233
• Report Number: 2032493-2021-00188
• Device Sequence Number: 3181796
• Product Code: OUT
• UDI-Device Identifier: 00842429106761
• UDI-Public: (01)00842429106761(11)200730(17)230630(10)20073057C
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 06/03/2021

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: 06/30/2023
• Device Model Number: FRED4508-PMA
• Device Lot Number: 20073057C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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: Required Intervention; Disability
• Patient Age: 43 YR