MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; FLOW DIVERTER

Model Number	FRED5514-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	07/28/2021
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 not returned to the manufacturer for analysis.Post procedural images were not provided; therefore the reported event could not be confirmed.The instructions for use identify stroke as a potential complication associated with use of the device.
Event or Problem Description
It was reported that after a fred stent was implanted in a patient on (b)(6) 2020, the patient presented to the hospital with stroke-like symptoms on (b)(6) 2021.There was a complete occlusion of the internal carotid artery.The patient was on asa and plavix for 3 months post procedure.
Additional Manufacturer Narrative
Imaging was provided of the stent placed in the siphon.The review of the provided media found the device had landed in the siphon but the images provided were inconclusive to verify the reported event as described.Without any additional images or status no further conclusions can be drawn.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12370807
• Report Number: 2032493-2021-00348
• Device Sequence Number: 11965703
• Product Code: OUT
• UDI-Device Identifier: 00842429106853
• UDI-Public: (01)00842429106853(11)200325(17)230228(10)20032553F
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: FRED5514-PMA
• Device Lot Number: 20032553F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1