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

Model Number	FRED4007-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance 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 analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies vessel stenosis or thrombosis as potential complications associated with use of the device.
Event or Problem Description
It was reported that treatment was performed for a middle cerebral artery (mca) aneurysm.The fred was successfully implanted and embolization coils were subsequently placed in the aneurysm.During the coil insertion, clot began to develop on the proximal portion of the fred.Integrilin was administered to the patient through the microcatheter and the thrombus resolved.There was no reported patient injury or sequelae.The patient has fully recovered.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10517219
• Report Number: 2032493-2020-00247
• Device Sequence Number: 3202943
• Product Code: OUT
• UDI-Device Identifier: 00842429106709
• UDI-Public: (01)00842429106709(11)190508(17)220430(10)19050852AM
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: FRED4007-PMA
• Device Lot Number: 19050852AM
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/10/2020
• 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