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

Model Number MV-F401727

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

Patient Problems Muscle Weakness (1967); Nausea (1970); Ischemia Stroke (4418)

Event Date 09/22/2021

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.A medical image was provided and an investigation of it is currently ongoing.The instructions for use (ifu) identifies stroke as a potential complication associated with use of the device.

Event Description

It was reported that on (b)(6) 2021, a fred stent was implanted in the left vertebral artery.Immediately after the procedure, imaging confirmed there were no issues with the stent placement.On (b)(6), the patient was discharged.Just before discharge, mri revealed no issues.There were also no abnormalities in the patient's physical condition.On (b)(6), the patient came to the hospital with nausea and unsteadiness that caused the patient to lean to the left when walking.Dsa confirmed there was no thrombus in the area where the fred was implanted.Ozagrel was administrated.On (b)(6), since there was no improvement, mra was performed again and cerebral infarction was found in the area of the aneurysm.Pletal was additionally administrated, and tapt was continued.The patient is not paralyzed, but is still experiencing nausea and unsteadiness, and will be hospitalized for a while, as rehabilitation is necessary.The physician commented that no in-stent thrombus was confirmed by dsa.The physician's belief is that the infarction occurred in either the perforating branch originating from the fred implantation site or the perforating branch originating from the target aneurysm.

Manufacturer Narrative

There was one image provided of two different 3d rotational angio views of the left vertebral artery, presumably prior to fred placement; no vessel measurement was provided.No procedural images were provided.From the event description, the investigation agrees with the physician's theory that if there was no stent thrombosis, the culprit was likely a perforator or pica infarct.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.

• 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: 12698406
• MDR Text Key: 278418338
• Report Number: 2032493-2021-00421
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 04987892121852
• UDI-Public: (01)04987892121852(11)201028(17)230930(10)20102856Q
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: MV-F401727
• Device Lot Number: 20102856Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• 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): Hospitalization; Required Intervention; Other