MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO; INTRALUMINAL STENT

Model Number	LEV2522-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Stenosis (2263); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Additional 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 stent was implanted in the patient and not returned for analysis.The event as described could not be confirmed.The instructions for use (ifu) identifies neurologic insufficiencies including stroke as a possible complication associated with use of the device.H3 other text : implanted in patient.
Event or Problem Description
It was reported that a patient that had a stent implanted in the mca bifurcation weeks prior presented with a m2 segment stroke.The stent had stenosis and thrombus.A balloon could not be inserted into the catheter for angioplasty due to stenosis.It was possible to aspirate thrombus at the proximal part of the stent.The patient has core infarct and left-sided weakness.

• Brand Name: LVIS EVO
• Common Device Name: INTRALUMINAL STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19218654
• Report Number: 2032493-2024-00342
• Device Sequence Number: 20568386
• Product Code: QCA
• UDI-Device Identifier: 00842429117767
• UDI-Public: (01)00842429117767(11)231025(17)260930(10)0000446323
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

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 Expiration Date: 09/30/2026
• Device Model Number: LEV2522-PMA
• Device Lot Number: 0000446323
• 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: 04/08/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Unknown