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

Model Number MV-F452827

Device Problem Material Separation (1562)

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

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

A search for non-conformance's 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.A procedure video was provided for review; however, the fred stent was not clearly visible.A slight filling defect is noted in the proximal parent artery.The device was implanted in the patient and not returned to the manufacturer for analysis; 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 after the fred was deployed to treat a right internal carotid artery (ica) aneurysm, an occlusion of the ica occurred.A separation ("floating") of the inner layer of the proximal stent was identified by angiography.Another stent was implanted to overlap the fred.The patient was asymptomatic and there was no reported sequela.One-week post-procedure, an occlusion within the stent was identified by mri imaging.No intervention was performed.The patient was asymptomatic and there was no reported sequela.The patient's condition was reported to be "not serious.".

• 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: 10988913
• MDR Text Key: 220898805
• Report Number: 2032493-2020-00366
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 04987892121913
• UDI-Public: (01)04987892121913(11)200423(17)230331(10)200423565
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: MV-F452827
• Device Lot Number: 200423565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• 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