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

Model Number MV-F351627

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

Patient Problem Thrombus (2101)

Event Date 07/07/2020

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 occlusion, vessel stenosis or thrombosis, and neurologic deficits as potential complications associated with use of the device.

Event Description

It was reported that treatment was performed for a right internal carotid artery (ica) aneurysm.The fred was implanted in the right pcom artery without difficulty or complications.Approximately fifteen (15) minutes after the patient was transferred to the icu post-procedure, the patient lost consciousness and left-sided hemiplegia appeared.Emergency angiography demonstrated a right ica occlusion.Heparin was administered and effient was delivered through the gastric tube, followed by an injection of argatroban.Thrombus aspiration was performed and the occluded ica was successfully recanalized.The patient's current condition is reported to be "favorable.".

• 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: 10429234
• MDR Text Key: 203636733
• Report Number: 2032493-2020-00214
• 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

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MV-F351627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2020
• 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