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

Model Number MV-F401227

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

Patient Problem Thrombus (2101)

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with this 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 not returned to the manufacturer for evaluation.The root cause of the complaint cannot be determined.The instructions for use (ifu) identifies vessel occlusion and vessel stenosis or thrombosis as potential complications associated with use of the device.

Event Description

It was reported that treatment was performed for a left internal carotid artery (ica) aneurysm.The fred stent was implanted in the ica at the aneurysm site successfully without incident.Four days later during another originally planned procedure, angiography demonstrated an occlusion within the fred stent.The patient had no neurological symptoms and there was no evidence of cerebral infarct in the images.No action was taken after the occlusion was identified and no additional intervention was performed.The patient was on dual antiplatelet therapy (clopidogrel and aspirin).The patient was reported to be in serious condition with some disability, but is improving.

• 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: 10365036
• MDR Text Key: 201669023
• Report Number: 2032493-2020-00194
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 04987892121845
• UDI-Public: (01)04987892121845(11)200111(17)221231(10)20011151Y
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: MV-F401227
• Device Lot Number: 20011151Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2020
• 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): Disability