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

Model Number MV-F401727

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/18/2021

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 procedure images were not provided; therefore, the alleged product issue cannot be confirmed.If additional information is received, microvention, inc.Will issue a supplemental mdr report.The instructions for use (ifu) identifies thrombus as potential complications associated with use of the device.

Event Description

It was reported that after implantation of the fred stent device, blood flow in the anterior cerebral artery (aca) decreased.Effient was administrated and percutaneous transluminal angioplasty (pta) was performed to remodel the stent to improve blood flow.At the time, the proximal flare of the stent was pushed with a guidewire, which shortened the stent and improved blood flow in the aca.The procedure was completed successfully.The patient was fine and has recovered.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12478451
• MDR Text Key: 272973758
• Report Number: 2032493-2021-00376
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 04987892121814
• UDI-Public: (01)04987892121814(11)200117(17)221231(10)20011754Q
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: MV-F401727
• Device Lot Number: 20051155H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2020
• 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