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

Model Number FRED4508

Device Problem Activation Failure (3270)

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

Event Date 03/23/2021

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 was implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies in-stent thrombosis as a potential complication associated with use of the device.

Event Description

It was reported that a fred 4508 stent was deployed to treat an internal carotid artery (ica) aneurysm.The patient was pretreated with a regimen of aspirin and clopidogrel starting five days prior to treatment.After deployment and detachment, the fred4508 stent foreshortened distally and the aneurysm was not completely covered.It was decided to use a second fred stent to cover the distal part of the aneurysm.During insertion of the microcatheter, the patient showed an ica occlusion and intravenous integrilin was administered.After a few minutes, all vessels were open and a remodeling balloon was used inside of the first fred 4508 stent.During the inflation of the balloon, an incomplete opening in the curve was visible.The second fred stent was then deployed.Dyna-ct at the end showed no vessel occlusions.

• Brand Name: FRED
• 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: 11713674
• MDR Text Key: 249235173
• Report Number: 2032493-2021-00151
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00811425021057
• UDI-Public: (01)00811425021057(11)190115(17)211231(10)19011552A
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: FRED4508
• Device Catalogue Number: 140205HES-V
• Device Lot Number: 19011552A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2019
• 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: 52 YR