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

Model Number	FRED2513-PMA
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this 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 not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies thrombosis as a potential complication associated with use of the device.
Event or Problem Description
It was reported that a fred stent was implanted to treat a ruptured aneurysm located at the bifurcation of the pericallosal and callosomarginal arteries.The fred moved during unsheathing but ultimately covered the aneurysm.A filling defect was noticed in the callosomarginal artery amd integrillin was administered.The filling defect was then observed to be resolved.The patient was placed on cangrelor post procedure and woke up with no neurological deficit.Mri showed no infarct the following day.

• Brand Name: FRED 21
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11676287
• Report Number: 2032493-2021-00135
• Device Sequence Number: 11640604
• Product Code: OUT
• UDI-Device Identifier: 00842429106587
• UDI-Public: (01)00842429106587(11)200916(17)230831(10)200916566
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/15/2021

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: FRED2513-PMA
• Device Lot Number: 200916566
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/15/2021
• 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: Required Intervention