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

Model Number	FRED2520-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Thrombus (2101)
Date of Event	06/01/2020
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 the stent remains implanted.The root cause could not be determined.The instructions for use (ifu) identifies vessel stenosis or occlusion and neorologic deficits including stroke and/or death as potential complications associated with use of the device.
Event or Problem Description
It was reported that the fred was successfully implanted in the anterior cerebral artery (aca) with no resheathing or device manipulations, and the fred opened appropriately.The patient had been anticoagulated prior to the procedure and anticoagulation was maintained during the case.The patient awoke post-procedure with aphasia and right-sided weakness, and approximately two (2) hours later was taken back to the procedure room.Dsa imaging confirmed aca hypoperfusion and a complete occlusion of the fred.Integrilin was administered, but without success; therefore, another stent was implanted within the fred, which resulted in only a minimal improvement to vessel patency.The patient was reported to have had a major stroke and is disabled.

• Brand Name: FRED 21
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10216039
• Report Number: 2032493-2020-00151
• Device Sequence Number: 14113739
• Product Code: OUT
• UDI-Device Identifier: 00842429106594
• UDI-Public: (01)00842429106594(11)190312(17)220228(10)19031252CM
• 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): 06/01/2020

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: 02/28/2022
• Device Model Number: FRED2520-PMA
• Device Lot Number: 19031252CM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/30/2020
• 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: Life Threatening; Required Intervention; Disability
• Patient Age: 43 YR