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

Model Number FRED4518-PMA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 03/31/2020

Event Type  Injury  

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 evaluation.Intraprocedural or post-procedural images were not provided for review; therefore, the reported event cannot be confirmed.The instructions for use identifies thrombosis and visual impairment as potential complications associated with use of the device.

Event Description

It was reported that during implantation of the fred to treat a left ophthalmic artery aneurysm, a filling defect was noted at the proximal end of the stent and the ophthalmic artery closed down.Integrilin was given, which restored flow.Six months post-procedure, a filling defect was still present at the proximal end of the stent and the ophthalmic artery was closed.The patient was reported to have blurred vision in the left eye.There was no reported device malfunction.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise; aliso viejo, CA 92656
• MDR Report Key: 10844823
• MDR Text Key: 216411069
• Report Number: 2032493-2020-00332
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106785
• UDI-Public: (01)00842429106785(11)190422(17)220331(10)19042253QM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: FRED4518-PMA
• Device Lot Number: 19042253QM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability