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

Model Number	FRED2508-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Thrombosis/Thrombus (4440)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance 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 remains implanted in the patient.Procedure images not provided; therefore, the alleged reported issue cannot be confirmed.The instructions for use (ifu) identifies clot formation, and coil misplacement as potential complications associated with use of the device.
Event or Problem Description
It was reported that the fred 21 device was successfully implanted to treat a fusiform aneurysm in estimated 2mm vessel.Upon angiographic review, the anatomy looked clear and stent was well opposed to the vessel walls.Post procedure, the patient had difficulty waking up and was not responsive on the right side of the body.Ct showed minor clot within the fred device and distal to device.The patient was taken back to ir and given ia tpa, which resolved the clot.The patient fully recovered and was discharged as originally planned.Pru level during the initial procedure was 150.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12837216
• Report Number: 2032493-2021-00446
• Device Sequence Number: 4353529
• Product Code: OUT
• UDI-Device Identifier: 00842429106570
• UDI-Public: (01)00842429106570(11)200106(17)221231(10)20010654RM
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: 12/31/2022
• Device Model Number: FRED2508-PMA
• Device Lot Number: 20010654RM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female