MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21; FLOW DIVERTER

Model Number	FRED2513-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/25/2022
Type of Reportable Event	Death
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 is not available for return to the manufacturer for analysis and procedure images not provided.Therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies stent thrombosis, stenosis of stented segment, and death as potential complications associated with use of the device.
Event or Problem Description
It was reported that the fred 21 flow diverter stent was used off-label to treat a site at the anterior communicating artery (acom).The physician reported that based on his visualization, the fred stent opened distally and was open and opposed to the wall; however, this could not be confirmed by imaging due to the patient's bone structure, and the imaging angle and poor quality.It was later discovered, after changing angles of image and doing a final run, that the central portion of the fred stent was not fully opened.Multiple attempts were made to try to access the central portion of the stent to open it, but they were unsuccessful.The vessel occluded, but cross fill was provided to the distal portion beyond the occlusion from another branch vessel.The physician ended the case with full flow beyond the stent occlusion.Reportedly, the patient later died that evening from complications related to thrombus.There is no indication of device issue.
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 is not available for return to the manufacturer for analysis and procedure images not provided.Therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies stent thrombosis, stenosis of stented segment, and death as potential complications associated with use of the device.
Event or Problem Description
It was reported that the fred 21 flow diverter stent was used off-label to treat a site at the anterior communicating artery (acom).The physician reported that based on his visualization, the fred stent opened distally and was open and opposed to the wall; however, this could not be confirmed by imaging due to the patient's bone structure, and the imaging angle and poor quality.It was later discovered, after changing angles of image and doing a final run, that the central portion of the fred stent was not fully opened.Multiple attempts were made to try to access the central portion of the stent to open it, but they were unsuccessful.The vessel occluded, but cross fill was provided to the distal portion beyond the occlusion from another branch vessel.The physician ended the case with full flow beyond the stent occlusion.Reportedly, the patient later died that evening from complications related to thrombus.There is no indication of device issue.

• Brand Name: FRED 21
• 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: 13592658
• Report Number: 2032493-2022-00068
• Device Sequence Number: 3860857
• Product Code: OUT
• UDI-Device Identifier: 00842429106587
• UDI-Public: (01)00842429106587(11)200929(17)230831(10)20092957N
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/25/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: FRED2513-PMA
• Device Lot Number: 20092957N
• 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: 01/25/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2020
• 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: Death
• Patient Age: 63 YR
• Patient Sex: Unknown