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 Problem Thrombus (2101)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

The lot number was unknown.It was not possible to search for non-conformances associated with the device's part/lot number combination.The device was not returned to the manufacturer for evaluation.The root cause of the complaint cannot be determined.The instructions for use (ifu) identifies vessel stenosis or thrombosis as potential complications associated with use of the device.

Event Description

It was reported that treatment was performed for an internal carotid artery (ica) aneurysm located at the c3 segment, around the ic-cave.The fred was implanted without incident in the ica at c2 to c3 and the patient was discharged from the hospital on clopidogrel.Approximately one week after stent implantation, the patient became symptomatic and returned to the hospital.The patient's pru value was 280.Thrombus was identified at the treatment site in front of the stent to within it.Thrombus aspiration was performed at the occlusion site and then balloon angioplasty (pta) was performed within the entire stent.The thrombus was resolved, recanalization was achieved successfully, and the patient has been recovering.There was no serious health damage or sequela.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10454944
• MDR Text Key: 204410372
• Report Number: 2032493-2020-00229
• Device Sequence Number: 1
• Product Code: OUT
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: MV-F401727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/26/2020
• 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): Required Intervention