MAUDE Adverse Event Report: FRED 21; FLOW DIVERTER

Model Number	FRED3009-PMA
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/30/2021
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.No procedure images provided; therefore, the alleged product issue cannot be verified.If additional information is received, microvention will issue a supplemental report.The instructions for use (ifu) identifies stent thrombosis and stenosis of stented segment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during the fred stent implantation procedure, the device did not fully open in the middle and proximal sections.The physician stated that large thrombus burden presented post deployment of the fred device.A balloon was used to post-dilate the device and drugs were administered.Reportedly, the thrombus resolved after some time and no issues or deficits were seen in patient, who was stable post procedure.

• Brand Name: FRED 21
• Common Device Name: FLOW DIVERTER
• MDR Report Key: 12746193
• Report Number: 2032493-2021-00433
• Device Sequence Number: 4480121
• Product Code: OUT
• UDI-Device Identifier: 00842429106617
• UDI-Public: (01)00842429106617(11)200928(17)230831(10)20092859E
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: FRED3009-PMA
• Device Lot Number: 20092859E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• 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