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

Model Number FRED3009-PMA

Device Problem Activation Problem (4042)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/12/2020

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.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies stent thrombosis as a potential complication associated with use of the device.

Event Description

It was reported that after implantation of a fred stent to treat a recurrent aneurysm of the right middle cerebral artery m1 segment, it was noticed that the distal struts of the stent were not fully apposed to the vessel wall and a small amount of non-occlusive thrombus had formed between the struts and the vessel wall.This thrombus was lysed with intravenous administration of integrilin and better wall apposition of the struts was achieved by performing balloon angioplasty of the fred device.The patient woke up from anesthesia neurologically intact, and remains intact four months after the procedure.

• Brand Name: FRED 21
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 11522327
• MDR Text Key: 240965136
• Report Number: 2032493-2021-00080
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106617
• UDI-Public: (01)00842429106617(11)190527(17)220430(10)190527537M
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: FRED3009-PMA
• Device Lot Number: 190527537M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2019
• 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: 43 YR