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

Model Number	FRED3009-PMA
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 is not available for return to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies stroke or tia (transient ischemic attack), migration or misplacement as potential complications associated with use of the device.
Event or Problem Description
It was reported that after successfully implanting the fred 21 stent in the m1 segment of middle cerebral artery (mca) aneurysm, the patient came back 6 days post implantation with a stroke.Angiogram run showed the stent migrated down the m1 vessel blocking the bifurcation.Intervention was taken and the patient was treated with direct catheter integrilin and drip.

• Brand Name: FRED 21
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12097221
• Report Number: 2032493-2021-00262
• Device Sequence Number: 11986469
• Product Code: OUT
• UDI-Device Identifier: 00842429106617
• UDI-Public: (01)00842429106617(11)200311(17)230228(10)20031153X
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/01/2021

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: 02/28/2023
• Device Model Number: FRED3009-PMA
• Device Lot Number: 20031153X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/30/2021
• 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