MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; FLOW DIVERTER

Model Number	FRED3524-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	06/11/2020
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.The root cause of the complaint cannot be determined.
Event or Problem Description
It was reported that the patient developed thrombus within the fred stent after implantation in the middle cerebral artery (mca).A slight stenosis was present in the mca prior to the procedure.There were no complications during deployment of the fred.A bolus and infusion of aggrastat and a bolus dose of cangrelor was administered during the procedure, which was successful at increasing vessel patency, and the patient was maintained on an aggrastat infusion drip for 18 hours post-procedure.The patient was discharged from the hospital "intact." there was no reported sequela.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10259428
• Report Number: 2032493-2020-00160
• Device Sequence Number: 2698119
• Product Code: OUT
• UDI-Device Identifier: 00842429106686
• UDI-Public: (01)00842429106686(11)190513(17)220430(10)19051355KM
• 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): 06/11/2020

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: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: FRED3524-PMA
• Device Lot Number: 19051355KM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/10/2020
• 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