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	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	11/11/2021
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 remains implanted in the patient and not available for analysis; however, procedure images were provided.The review of the provided images found ica occluded just distal to aneurysm.The stent markers appear to be in same position as immediately after implantation.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The instructions for use (ifu) identifies stent thrombosis as a potential complication associated with use of the device.
Event or Problem Description
It was reported that the fred device clotted off at 1 year follow-up.Index procedure described as normal, single deployment of the stent with no recapture of stent required.The patient's p2y12 was in range during the procedure and the physician had the patient on dapt protocol post procedure.Patient currently still on dapt.There is no follow up treatment planned at this time.At the time of this report the patient is doing well and have cross fill through the anterior communicating artery (acom).

• 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: 12971016
• Report Number: 2032493-2021-00483
• Device Sequence Number: 11866087
• Product Code: OUT
• UDI-Device Identifier: 00842429106761
• UDI-Public: (01)00842429106761(11)200523(17)230430(10)200523525
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/11/2021

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: 04/30/2023
• Device Model Number: FRED4508-PMA
• Device Lot Number: 200523525
• 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: 11/11/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2020
• 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 Sex: Male