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

Model Number FRED4017-A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/30/2022

Event Type  Injury  

Event Description

It was reported that the fred stent was deployed in the carotid artery to treat an ophthalmic artery aneurysm; however, the fred did not open well in the artery curve.After fully deploying and detaching the fred, the physician tried to go through the stent with a guide wire to follow with a balloon and dilate the unopened area; however, during the maneuvers the fred dropped into the aneurysm with no ability to remove it, which resulted in a complete occlusion of the carotid artery.Due to a good acom artery, the other side was compensating over the occluded side.The patient woke up with no neurological damage due to the flow compensation from the other side.

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.The instructions for use (ifu) identifies device misplacement as potential complications associated with use of the device.

• Brand Name: FRED
• 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: 15421046
• MDR Text Key: 299902900
• Report Number: 2032493-2022-00365
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00816777025548
• UDI-Public: (01)00816777025548(11)201111(17)231031(10)201111595
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: FRED4017-A
• Device Lot Number: 201111595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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): Other
• Patient Age: 54 YR
• Patient Sex: Female