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

Model Number FRED4026-PMA

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with this 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 not returned to the manufacturer for analysis.The root cause cannot be determined,.

Event Description

It was reported that treatment was performed for a left ophthalmic internal carotid artery (ica) aneurysm.There was significant vessel diameter discrepancy and vessel tortuosity throughout the petrous and cavernous ica.The fred was deployed around the carotid siphon.The distal and middle sections of the device opened well; however, the proximal end did not open after deployment.Attempts to open the proximal end of the fred with the delivery wire, the microcatheter, and the guide catheter were unsuccessful.During the attempt to retrieve the stent with a gooseneck snare, the proximal finished ends were pushed forward into the open section of the fred.Subsequent angiographic images demonstrated a patent fred and robust flow through the device.There was no evidence of thrombus.The device was left implanted at the intended treatment site.There was no reported patient injury.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 9941824
• MDR Text Key: 189845660
• Report Number: 2032493-2020-00095
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106747
• UDI-Public: (01)00842429106747(11)190306(17)220228(10)19030653QM
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: FRED4026-PMA
• Device Lot Number: 19030653QM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• 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: 70 YR