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

Model Number UNKNOWN

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

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422); Vascular Dissection (3160); Ischemia Stroke (4418)

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the part/lot number combinations of the actual devices could not be performed, as the part and lot numbers were not provided.The devices were implanted in the patient and not returned to the manufacturer for analysis.Procedural or post-procedural images were not provided; therefore the reported event could not be confirmed.The instructions for use identifies stenosis of stented segment and stroke as potential complications associated with use of this device.

Event Description

As reported through the article titled, "safety and efficacy results of the flow redirection endoluminal device (fred) stent system in the treatment of intracranial aneurysms: us pivotal trial," after undergoing aneurysm treatment with a fred stent, stenosis of 50% at the 12-month follow-up was observed in six patients.Two of the six patients with stenosis were symptomatic, and three of the six had complete parent artery occlusions.The symptomatic patient with complete occlusion presented at day 345 with multiple territory thromboembolic strokes.The second patient with symptomatic stenosis had embolic strokes on the day of treatment but recovered to nihss and mrs scores of 0 by day 30, although kinking and severe stenosis of the device was noted at angiographic follow-up.The four remaining patients were asymptomatic, although two of these patients had complete parent artery occlusions thought to be due to carotid artery dissections.".

• 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: 12364146
• MDR Text Key: 268050804
• Report Number: 2032493-2021-00344
• Device Sequence Number: 1
• Product Code: OUT
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Disability