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

Model Number	FREDX2525-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	09/01/2022
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 rupture or perforation of the aneurysm as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during treatment of a distal mca branch using a fred x21, a bleed occurred during access/deployment of the device in the proximal entry into the large aneurysm.The vessel appeared diseased at the point of the bleed.Fault was not attributed to the fred x device.A second fred x21 was successfully placed inside the first reported fred x21 at the proximal end of the aneurysm and the bleed appeared to dissipate.
Additional Manufacturer Narrative
Additional information was received via phone call with the sales representative indicating the following: in addition to the dissection at the mca branch, another dissection occured at the carotid artery at the start of the case.This was not initially reported.The headway and fred devices were not in the patient at this time.It was stated the vessel was very diseased and thought to have been the attributing factor for both dissections.

• 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: 15392868
• Report Number: 2032493-2022-00361
• Device Sequence Number: 6179289
• Product Code: OUT
• UDI-Device Identifier: 00842429114230
• UDI-Public: (01)00842429114230(11)220307(17)250228(10)0000163983
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

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: 02/28/2025
• Device Model Number: FREDX2525-PMA
• Device Catalogue Number: FREDX2525
• Device Lot Number: 0000163983
• 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: 09/02/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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: Required Intervention
• Patient Sex: Unknown