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

Model Number	FRED4017-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Muscle Weakness/Atrophy (1967); Obstruction/Occlusion (2422); Speech Disorder (4415); Thrombosis/Thrombus (4440)
Date of Event	03/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 device was implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural or post-procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies stent thrombosis, stroke, aphasia, and hemiplegia as a potential complication associated with use of the device.
Event or Problem Description
It was reported that a fred stent was implanted in the patient from the right m1 segment of the middle cerebral artery (mca) to an aneurysm of the supraclinoid segment of the internal carotid artery (ica) to treat three aneurysms in tandem: 3mm denovo right ica terminus aneurysm, 3.3mm recurrent right a1 segment of anterior cerebral artery aneurysm, 2.7mm denovo right anterior choroidal artery aneurysm.The patient was discharged home and prescribed ticagrelor and aspirin.11 days after implantation of the stent, the patient suddenly developed left-sided weakness and difficulty speaking.The patient was taken to another hospital, where a cta showed thrombosis of the right internal carotid artery, fred device and right m1 segment of the mca.No intervention was undertaken.The patient is wheelchair bound 1 year after the event (modified rankin scale 4).

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11530686
• Report Number: 2032493-2021-00082
• Device Sequence Number: 19957656
• Product Code: OUT
• UDI-Device Identifier: 00842429106730
• UDI-Public: (01)00842429106730(11)190318(17)220228(10)19031854ZM
• 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): 03/19/2021

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: 02/28/2022
• Device Model Number: FRED4017-PMA
• Device Lot Number: 19031854ZM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/19/2021
• 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: Disability
• Patient Age: 59 YR