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

Model Number	MV-F402627
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Thrombosis/Thrombus (4440)
Date of Event	05/22/2021
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 evaluation.Intraprocedural and post-procedural images were not provided.The reported event could not be confirmed.The instructions for use identifies thrombosis as a potential complication associated with use of the device.
Event or Problem Description
It was reported that the patient had a thrombotic occlusion and vertebral artery aneurysm.Three days after the stenting, paralysis was observed in the pica territory.Angiography revealed an occlusion of the stented part of the vertebral artery where the fred was implanted.During stenting, the patient was confirmed to be a low responder to clopidogrel, so cilostazol was administered instead of aspirin.No other additional treatment was performed.The patient was reported to be in a "serious condition," but they recovered.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12072300
• Report Number: 2032493-2021-00258
• Device Sequence Number: 14434736
• Product Code: OUT
• UDI-Device Identifier: 00842429106709
• UDI-Public: (01)00842429106709(11)190507(17)220430(10)190507547M
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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: 03/31/2023
• Device Model Number: MV-F402627
• Device Lot Number: 20040254J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/26/2021
• 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