MAUDE Adverse Event Report: MICROVENTION, INC. FRED X21; FLOW DIVERTER

Model Number	FREDX3013-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during treatment of a ruptured m3 aneurysm, the proximal vasculature was reported to be tortuous.The fred was successfully deployed.The patient was reported to wake up okay.Approximately 2 hours post procedure deficit was reported.A scan revealed a huge iph and was sent to the or for a stat craniotomy.The cause of the iph is unknown.The patient was reported 1-5-1 on gcs and intubated.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be verified.The instructions for use (ifu) identifies rupture as a potential complication associated with use of the device.

• Brand Name: FRED X21
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15617797
• Report Number: 2032493-2022-00406
• Device Sequence Number: 20818566
• Product Code: OUT
• UDI-Device Identifier: 00842429114254
• UDI-Public: (01)00842429114254(11)210426(17)240331(10)0000145838
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

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: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: FREDX3013-PMA
• Device Catalogue Number: FREDX3013
• Device Lot Number: 0000145838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown