MAUDE Adverse Event Report: MicroVention, Inc. LVIS EVO; Intracranial Coil-Assist Stent

Model Number	LEV3018-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	03/14/2026
Type of Reportable Event	Serious Injury

• Brand Name: LVIS EVO
• Common Device Name: Intracranial Coil-Assist Stent
• Manufacturer (Section D): MicroVention, Inc.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; +1(714)247-8000
• MDR Report Key: 50876580
• Report Number: 2032493-2026-08256
• Device Sequence Number: 13067417
• Product Code: QCA
• UDI-Device Identifier: 00842429117781
• UDI-Public: (01)00842429117781(11)241120(17)271031(10)0000769846
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Operator of Device: Health Professional
• Device Model Number: LEV3018-PMA
• Device Lot Number: 0000769846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown