MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21; FLOW DIVERTER

Model Number FRED2513-PMA

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

Patient Problems Loss of Vision (2139); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 05/06/2021

Event Type  Injury  

Manufacturer Narrative

The device was implanted in the patient and not returned to the manufacturer for analysis.Post procedural images were not provided; therefore the reported event could not be confirmed.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 instructions for use (ifu) identifies hemiplegia, ischemic stroke and stent thrombosis as potential complications associated with use of the device.

Event Description

It was reported that a fred jr.Stent was implanted to treat an aneurysm of the fetal posterior cerebral artery.The stent was deployed without issue and stasis was observed to be forming inside of the aneurysm.Four hours post procedure, thrombus was observed to be forming inside of the stent.Balloon angioplasty was performed, which restored flow, but the stent continued to form thrombus.It was the physician's belief that the clot formation inside the aneurysmal sac was so severe that it went down into the fred jr.A follow-up the next day showed re-profusion, but the patient had already had a stroke and they were blind on right side.Integrilin was administered.

• Brand Name: FRED 21
• 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: 11943493
• MDR Text Key: 254511792
• Report Number: 2032493-2021-00219
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106587
• UDI-Public: (01)00842429106587(11)201007(17)230930(10)201007563
• 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: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• 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: FRED2513-PMA
• Device Lot Number: 201007563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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; Required Intervention; Disability