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

Model Number FRED4508-PMA

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

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

Event Date 11/11/2021

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; however, procedure images were provided.The review of the provided images found ica occluded just distal to aneurysm.The stent markers appear to be in same position as immediately after implantation.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The instructions for use (ifu) identifies stent thrombosis as a potential complication associated with use of the device.

Event Description

It was reported that the fred device clotted off at 1 year follow-up.Index procedure described as normal, single deployment of the stent with no recapture of stent required.The patient's p2y12 was in range during the procedure and the physician had the patient on dapt protocol post procedure.Patient currently still on dapt.There is no follow up treatment planned at this time.At the time of this report the patient is doing well and have cross fill through the anterior communicating artery (acom).

• 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: 12971016
• MDR Text Key: 284992219
• Report Number: 2032493-2021-00483
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106761
• UDI-Public: (01)00842429106761(11)200523(17)230430(10)200523525
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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: FRED4508-PMA
• Device Lot Number: 200523525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2020
• 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
• Patient Sex: Male