MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21; FLOW DIVERTER

Model Number FRED3021-PMA

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

Patient Problems Speech Disorder (4415); Thrombosis/Thrombus (4440)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

A search for non-conformance's associated with this 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.Additionally, procedural images were not provided; therefore, the alleged event cannot be confirmed.The instructions for use identifies stent thrombosis and thromboembolic event as potential complications associated with use of the device.

Event Description

It was reported that 12 hours after implantation of the fred in the supraclinoid segment of the ica, thrombus was identified in the artery.The patient experienced dysarthria.Reopro and heparin were administered to the patient.There was no reported malfunction of the fred.

• Brand Name: FRED 21
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 11042424
• MDR Text Key: 224024690
• Report Number: 2032493-2020-00378
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106631
• UDI-Public: (01)00842429106631(11)191101(17)221031(10)19110154LM
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: FRED3021-PMA
• Device Lot Number: 19110154LM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2019
• 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
• Patient Age: 44 YR