MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO; INTRACRANIAL COIL-ASSIST STENT

Model Number	LEV2522-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Muscle Weakness/Atrophy (1967)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's 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 implanted in the patient and not available for return to the manufacturer for analysis.Imaging and medical reports were not provided.The event as described could not be confirmed.Additional information is being sought for the event and if more information is received, an analysis will be performed and a supplemental report will be submitted.
Event or Problem Description
It was reported that a patient woke up from their procedure "abnormal" with left sided arm and leg weakness.They were administered aspirin and plavix and their mrs score improved to 1.

• 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 ; 7142478000
• MDR Report Key: 19544822
• Report Number: 2032493-2024-00475
• Device Sequence Number: 12688861
• Product Code: QCA
• UDI-Device Identifier: 00842429117767
• UDI-Public: (01)00842429117767(11)231121(17)261031(10)0000461600
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2024

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: Other
• Device Model Number: LEV2522-PMA
• Device Lot Number: 0000461600
• 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: 05/29/2024
• Initial Report FDA Received Date: 06/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HYDROCOIL 10 - 7210-0304
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 80 KG