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

Model Number	FRED3014-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	03/02/2020
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 not returned to the manufacturer for evaluation, as it was implanted in the patient.The root cause could not be determined.
Event or Problem Description
It was reported that treatment was performed for an a-com aneurysm on (b)(6) 2020.The fred was implanted in a satisfactory position without incident and the patient was discharged home.Three days post-procedure on (b)(6) 2020, the patient presented with stroke symptoms and a clot was identified within the fred.The patient was taken to the interventional radiology lab lab for an angiogram and treated with intra-arterial thrombolysis medications.The current patient's condition is unknown.

• Brand Name: FRED 21
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9925570
• Report Number: 2032493-2020-00088
• Device Sequence Number: 14276984
• Product Code: OUT
• UDI-Device Identifier: 00842429106624
• UDI-Public: (01)00842429106624(11)190314(17)220228(10)19031454NM
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: FRED3014-PMA
• Device Lot Number: 1907155Y6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/03/2020
• 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