MAUDE Adverse Event Report: MICROVENTION, INC. FRED X27; FLOW DIVERTER

Model Number	FREDX5026-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one day post placement of a fred x stent, the patient was re-admitted with a left hemispheric stroke.There were no complications during the placement of the fred x stent in the left ica.The vessel's proximal size was approximately 4.5 mm.The vessel's distal size was approximately 3.83 mm.One day post procedure, however, the patient had a large ophthalmic segment aneurysm and was re-admitted with a left hemispheric stroke.A clot was noticed on the distal portion of the fred x device.It was reported that the patient was non-compliant with post-procedure treatment protocol.
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 remains implanted in the patient and is therefore not available for return to the manufacturer for analysis.Additionally, the procedural images were not made available for review.On this basis, the event as described could not be confirmed.The instructions for use (ifu) identifies stroke or tia (transient ischemic attack as a potential complication associated with use of the device.

• Brand Name: FRED X27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14436984
• Report Number: 2032493-2022-00201
• Device Sequence Number: 5898095
• Product Code: OUT
• UDI-Device Identifier: 00842429114469
• UDI-Public: (01)00842429114469(11)211214(17)241130(10)0000132272
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/03/2022

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: 11/30/2024
• Device Model Number: FREDX5026-PMA
• Device Catalogue Number: FREDX5026
• Device Lot Number: 0000132272
• 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: 05/03/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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
• Patient Sex: Female