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

Model Number FRED5014-PMA

Device Problem Activation Failure (3270)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during the manufacturing of the device.The device was implanted in the patient and was not returned to the manufacturer; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies vessel occlusion and vessel stenosis or thrombosis as potential complications associated with use of the device.

Event Description

It was reported that upon deployment of the fred in the right internal carotid artery (ica), the stent was not fully opened.The anterior cerebral artery (aca) and the ica shut down.A balloon was inflated within the stent, which fully opened the stent and restored flow to the aca and ica.

• 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 drive; aliso viejo, CA 92656
• MDR Report Key: 10688083
• MDR Text Key: 211628128
• Report Number: 2032493-2020-00287
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106822
• UDI-Public: (01)00842429106822(11)191016(17)220930(10)19101653WM
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Model Number: FRED5014-PMA
• Device Lot Number: 19101653WM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2019
• 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