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 Codes	Loss of Vision (2139); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was implanted in the patient and not returned to the manufacturer for analysis.Post procedural images were not provided; therefore the reported event could not be confirmed.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 instructions for use (ifu) identifies hemiplegia, ischemic stroke and stent thrombosis as potential complications associated with use of the device.
Event or Problem Description
It was reported that a fred jr.Stent was implanted to treat an aneurysm of the fetal posterior cerebral artery.The stent was deployed without issue and stasis was observed to be forming inside of the aneurysm.Four hours post procedure, thrombus was observed to be forming inside of the stent.Balloon angioplasty was performed, which restored flow, but the stent continued to form thrombus.It was the physician's belief that the clot formation inside the aneurysmal sac was so severe that it went down into the fred jr.A follow-up the next day showed re-profusion, but the patient had already had a stroke and they were blind on right side.Integrilin was administered.

• Brand Name: FRED 21
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11943493
• Report Number: 2032493-2021-00219
• Device Sequence Number: 17232590
• Product Code: OUT
• UDI-Device Identifier: 00842429106587
• UDI-Public: (01)00842429106587(11)201007(17)230930(10)201007563
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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: 09/30/2023
• Device Model Number: FRED2513-PMA
• Device Lot Number: 201007563
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 06/04/2021
• 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: Other; Required Intervention; Disability