MAUDE Adverse Event Report: MICROVENTION, INC LVIS; INTRACRANIAL NEUROVASCULAR STENT

Model Number 214049-LVIS

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2019

Event Type  No Answer Provided  

Event Description

There was incomplete expansion of the low-profile visualized intraluminal support (lvis) intraluminal support device which promoted accumulation of thrombus at the dissection site and with inability to traverse the device to affect deployment.

• Brand Name: LVIS
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MICROVENTION, INC; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 9218775
• MDR Text Key: 163175190
• Report Number: 9218775
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Device Operator: No Information
• Device Model Number: 214049-LVIS
• Device Catalogue Number: 214049-LVIS
• Device Lot Number: 16121329M
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Type of Device Usage: N
• Patient Sequence Number: 1