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

Model Number FRED3009-PMA

Device Problem Difficult to Open or Close (2921)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/30/2021

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 remains implanted in the patient and not available for analysis.No procedure images provided; therefore, the alleged product issue cannot be verified.If additional information is received, microvention will issue a supplemental report.The instructions for use (ifu) identifies stent thrombosis and stenosis of stented segment as potential complications associated with use of the device.

Event Description

It was reported that during the fred stent implantation procedure, the device did not fully open in the middle and proximal sections.The physician stated that large thrombus burden presented post deployment of the fred device.A balloon was used to post-dilate the device and drugs were administered.Reportedly, the thrombus resolved after some time and no issues or deficits were seen in patient, who was stable post procedure.

• Brand Name: FRED 21
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12746193
• MDR Text Key: 279928724
• Report Number: 2032493-2021-00433
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106617
• UDI-Public: (01)00842429106617(11)200928(17)230831(10)20092859E
• Combination Product (y/n): N
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: FRED3009-PMA
• Device Lot Number: 20092859E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• 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